FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2

1. Device Operational Issue

a Device Operates Differently than Exp i. Device Displays Error Message

ii. Device Stops Intermittently
iii. Failure to Adhere or Bond
iv. Failure to Fire
v. Failure to Obtain Sample
vi. Failure to Prime
vii. Misassembled
viii. Prompts will not clear
ix. Therapy Delivered to Incorrect Body Area
x. Unintended Ejection
b Calibration Issue
i. Failure to Calibrate

c Computer Software Issue

Level 3

ii. Overcorrection
i. Application Network Issue
ii. Application Program Issue

iii. Data Issue

iv. Computer Operating System Issue
v. Computer System Security Issue
vi. Data Back-up Problem

d Connection Issue

e Deployment Issue

f Electrical Issue

vii. Date-related Software Issue

i. Blocked Connection
ii. Decoupling
iii. Disconnection
iv. Failure to Disconnect
v. Fitting Problem
vi. Loose or Intermittent Connection
vii. Misconnection
i. Difficult to Display
ii. Failure to Deploy
iii. Failure to Expand
iv. Failure to Separate
v. Premature Deployment
vi. Self-Activation or Keying
i. Capturing Issue

ii. Continuous Firing

iii. Power Source Issue

Level 4

Level 6

1. Calibration Error
2. Failure to Calibrate
3. Imprecision

1.
2.
3.
4.
5.

1.
2.
1.
2.
1.
1.
2.

Application Interface becomes nonfunctional or program exits abnormally

Application Program Version or Upgrade Problem
Incorrect Error Code
Problem With Software Installation
Programming Issue
a. Incorrect Software Programming Calci. Dose Calculation Error due to Software Problem
ii. Parameter Calculation Error due to Software Problem
iii. Power Calculation Error Due to Software Problem
b. Medication Error
Loss of Data
Patient Data Issue
Operating System Becomes Nonfunctional
Operating System Version or Upgrade Problem
Unauthorized Access to Computer System
a. Application Security Issue
Failure to Back-up
Failure to Convert to Back-Up

1. Difficult or Delayed Activation

1.
2.
3.
4.

Failure to Cauture
High Capture Threshold
Intermittent Caprute
Unstable Capture Threshold

1. Battery Issue

a. Battery Impedance Issue

2. Charging Issue

b. Failure to run on Portable Mode

c. Low Battery
d. Premature Discharge of Battery
a. Aborted Charge
b. Delayed Charge Time
c. Failure to Charge
a. Failure to run on AC/DC

3. Failure to Power-Up
4. Unintended Energization
iv. Device Inoperable
v. Device Sensing Issue

Level 5

10/28/2015

1. Failure to Sense

i. High Battery Impedance

ii. Low Battery Impedance

FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2

Level 3

vi. Failure to Conduct

vii. Failure to Convert Rhythm
viii. Failure to Interrogate
ix. Failure to Pace or Properly Pace

x. Failure to Shock or Properly Shock

g Incompatibility Problem

xi. Grounding Malfunction

i. Component or Accessory Incompatibility
ii. Device-Device Incompatibility
iii. Patient-Device Incompatibility

h Infusion or Flow Issue

iv. Measurement System Incompatibility

i. Deflation Issue
ii. Excess Flow or Over-infusion
iii. Filling Problem

iv. Filtration Issue

v. Improper Flow or Infusion

vi. Inflation Issue

vii. Insufficient Flow or Underinfusion
viii. No Flow

ix. Obstruction within Device

x. Pressure Issue

Level 4

Level 5

2. Invalid Sensing

a. Decreased Sensitivity
b. Failure to Analyze Rhythm
c. Failure to Select Signal
d. High Sensing Threshold
e. Incorrect Interpretation of Rhythm
f. Increased Sensitivity
g. Loss of Threshold
h. Low Sensing Threshold
i. Over-Sensing
j. Sensing Intermittently
k. Under-Sensing

1.
1.
2.
3.
4.
5.
6.
7.
8.
1.
2.
3.
4.

Difficult to Interrogate
Failure to Convert Rhythm
Failure to Spike
Inaccurate Synchronization
No Pacing
Pacer Found in Back-up Mode
Pacer Asynchronously
Pacing Inadequately
Pacing Intermittently
Failure to Deliver Counter-Shock
Failure to Discharge
Inappropriate Shock
Intermittent Shock

10/28/2015

Level 6

a. Pocket Stimulation

1. Accessory Incompatibility
2. Component Incompatibility
1. Rejection
2. Size Incorrect for Patient

1.
2.
3.
4.
1.
2.
1.
2.
3.
4.
5.
6.
7.
8.
9.

Inability to Auto-fill
Overfill
Short Fill
Volume Accuracy Issue
Inadequate Filtration Process
Ultra-filtration
Bleed Back
Free or Unrestricted Flow
Gradient Increase
Inaccurate Delivery
Inaccurate Flowrate
Intermittent Infusion
Reflux within Device
Restricted Flowrate
Tidal Volume Fluctuations

1.
2.
3.
1.

Failure to Deliver
Failure to Infuse
Inability to Irrigate
Occlusion within Device

1. Decrease in Pressure
2. Increase in Pressure
3. No Pressure

a. Blockage within Device or Device Component

b. Device Clogged
c. Difficult to Flush

FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2

Level 3

Level 4

xi. Pumping Issue

1.
2.
3.
4.
5.
1.
2.
3.
1.
2.
3.
4.

xii. Suction Issue

i Output Issue

i. Improper Device Output

Decreased Pump Speed

Failure to Pump
Increased Pump Speed
Pre- or Post-Pumping Problem
Pumping Stopped
Aspiration Issue
Decrease in Suction
Increase in Suction
False Device Output
Image Orientation Incorrect
Improper Gas Output
Improper Prompts

5. Incorrect Display

6. Output Above Specifications

7. Output Below Specifications
8. Output Energy Incorrect

ii. Incorrect or Inadequate Result

9. Poor Image Quality

10. Therapeutic or Diagnostic Output Failure
1. Display Misread
2. False Negative Result
3. False Positive Result
4. False Reading from Device Noncompliance
5. High Readings
6. Incorrect Measurement
7. Incorrect or Inadequate Test Results

Level 5

10/28/2015

Level 6

a. Image Reversal
a. Inaudible Voice Prompts
b. No Voice Prompts
a. Erratic Display
b. Image Display Error
c. Issue with Displayed Error Message
d. Unable to Obtain Readings
a. Radiation Overexposure
a. Radiation Underexposure
a. Energy Output to Patient Tissue Incorrect
b. Energy Spectrum Incorrect
c. Failure to Deliver Energy
a. Image Resolution Poor

a. Artifact
b. High Test Results
c. Low Test Results
Missing Test Results

8. Low Readings
9. Unexpected Therapeutic Results
j Protective Measure Issue

iii. No Device Output

i. Device Alarm Issue

ii, Fail-Safe Mechanism Failure

iii. Failure to Auto Stop

iv. Premature Indicator Activation
v. Reset Issue

2. Facilities Issue

a Device Maintenance Issue

b Disinfection or Sterilization Issue at

1. False Alarm
2. Improper Alarm

1.
2.
3.
1.
1.
2.
1.
2.
3.

a. Alarm not Visible

b. Defective Alarm
c. Delayed Alarm
d. Low Audible Alarm
e. Not Audible Alarm

Fail-Safe Design Failure

Failure of Device to Self-Test
No Failsafe Mechanism
Plunge
Premature Elective Replacement Indicator
Premature End-of-Life Indicator
Failure to Reset
Failure to Zero
Inappropriate or Unexpected Reset

vi. Shielding Failure

i. Failure to Service
ii. Inadequate Service
iii. Lack of Maintenance documentation or Guidelines
iv. Maintenance Does Not Comply with Manufacturer's Recommendations
i. Contamination During Use
1. Contamination of Device Ingredient or Reagent
2. Device Contamination with Biological Material
3. Foreign Matter Present in Device

a. Bacterial Contamination of Device

b. Device Contamination with Blood or Blood Product

FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2

10/28/2015

Level 3

Level 4

Level 5

ii. Device Cleaning Issue

1. Device Disinfection or Sterilization Issue

a. Failure to Disinfect
b. Failure to Sterilize
a. Failure to Flush
b. Failure to Remove Enzymatic Cleaner

2. Device Rinsing Issue

Level 6

3. Residue after Decontamination

c Environmental Control or Utility Issue i. Ambient Noise Issue
ii. Ambient Temperature Issue
iii. Biological Environmental Factor
iv. Device Expiration Issue
v. Device Unsafe to Use in Environment
vi. Electrical Power Problem

vii. Environmental Particulates

viii. Inadequate Lighting
ix. Medical Gas Supply Problem
x. Moisture or Humidity Problem
xi. Ventilation Issue in Device Environment

3. Human Factors Issue

d Inadequate Storage
e Installation-Related Problem
a Human-Device Interface Issue

b Inadequate Training
c Instruction for Use Issue
d Use of Device Issue

4. Physical Property Issue

a Chemical Issue

1.
1.
1.
2.

Changes in Ambient Temperature in Device Environment

Fungus in Device Environment
Expiration Date Error
Shelf Life Exceeded

1. Emergency Power Failure

2. Loss of Power
3. Power Conditioning Issue

1. Moisture Damage
1. Fogging
2. Fumes or Vapors

i. Device Difficult to Maintain

ii. Device Difficult to Setup or Prepare
iii. Difficult to Program or Calibrate
iv. Inadequate User Interface
i. Inadequate Instructions for healthcare professional
ii. inadequate instructions for non-healthcare professional
i. Device Handling Issues
ii. Improper or Incorrect Procedure or Method
iii. Misassembled by Users
iv. Use of Incorrect Control Settings
v. User used Incorrect Product of intended use.
i. Chemical Spillage
ii. Device emits Odor
iii. Device Ingredient or Reagent Issue
1. Biocompatibility Issue
2. High pH
3. Sediment, Precipitate or Deposit in Device or Device Ingredient

iv. Flashpoint Threshhold Met

v. Improper Chemical Reaction
b Communication or Transmission Issuei. Failure to Read Input Signal
ii. Failure to Transmit Record
iii. Radio Signal Problem
iv. Telemetry Discrepancy
c Electronic Property Issue
i. Arcing
ii. Circuit Failure

iii. Electrical Overstress

iv. Electromagnetic Issue

v. Failure to Shut Off

vi. Impedance Issue

1.
2.
1.
2.
3.

Arcing at Electrodes
Arcing at Paddles
Capacitive Coupling
Electrical Shorting
Intermittent Connection

1.
2.
3.
1.
1.
2.

Electromagnetic Interference
Electro-Static Discharge
Radiofrequency Interference
Device Remains Active
High Impedence
Low Impedence

a. Clumping in Device or Device Ingredient

b. Coagulation in Device or Device Ingredient
c. Cross Reactivity
d. Particulates
e. Precipitate in Device or Device Ingredient

FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2
d Manufacturing or Shipping Issue

Level 3

ix. Product Quality Issue

e Material Integrity Issue

Level 4

vii. Spark
i. Component Missing
ii. Device Marking Issue
iii. Defective Item
1. Defective Component
iv. Device Damaged Prior to Use
1. Shipping Damage or Problem
v. Device Misassembled During Manufacturing or Shipping
vi. Incorrect Device or Component Shipped
vii. Item Contaminated during Manufacturing o1. Delivered as Unsterile Product
viii. Packaging Issue
1. Device Packaging Compromised

i. Break

ii. Buckled Material

iii. Burst
iv. Crack
v. Degraded
vi. Material Deformation

2.
1.
2.
3.
1.
2.
3.

Difficult to Open or Remove Packaging Material

Dull
Nonstandard Device or Device Component
Out-Of-Box Failure
Fracture
Loss or Failure to Bond
Material Fragmentation

1.
2.
3.
4.
5.
6.
7.

Dent in Material
Failure to Fold
Failure to Unfold or Unwrap
Material Frayed
Material Invagination
Material Rigid or Stiff
Material Twisted

Level 5

a. Bent

8. Melted
9. Mushroomed
10. Stretched

f Mechanical Issue

1. Metal Shedding Debris

1.
2.
3.
4.

Cut in Material
Hole in Material
Material Puncture
Material Rupture

xi. Material Protrusion

xii. Material Opacification
xiii. Material Separation
xiv. Scratched Material
1. Device Abrasion from Instrument or another object
xv. Split
xvi. Torn Material
i. Delivery System Failure
ii. Detachment of Device or Device Componen1. Detachment of Device COmponent
2. Disability
iii. Device or Device Component Damaged by Another Device
iv. Dislodged or Dislocated
1. Component Falling
2. Device or Device Component Fragments Location Unknown
3. Excape
4. Slippage of Device or Device Component
v. Leak
1. Fluid Leak

Level 6

a. Incomplete or Missing Packaging

b. Tear, Rip or Hole in Device Packaging
c. Unsealed Device Packaging
a. Failure to Unwrap

b. Coiled
c. Knotted
d. Material Torqued
e. Uncoiled

vii. Material Discolored

viii. Material Disintegration
ix. Material Distortion
x. Material Perforation

10/28/2015

a. Hot Oil Leak

b. Peri-Valvular Leak

i. Folded
ii. Kinked
iii. Wrinkled

FDA Medical Device Problem Codes

Patrick Lynch

Level 1

Level 2

Level 3

vi. Mechanical Jam

vii. Mechanics Altered

viii. Misfire
ix. Noise, Audible
x. Osseointegration Issue
xi. Positioning Issue

xii. Retraction Issue

xiii. Structural Problem

xiv. Unintended Movement

g Optical Issue

h Temperature Issue

5.
6.
7.
8.
9.

Missing Value Reason

No Code Available
No Information
No Known Device Problem
Not Applicable

i. Light Interference
ii. Optical Decentration
iii. Optical Discoloration
iv. Optical Distortion
v. Optical Obstruction
i. Burn of Device or Device Component
ii. Excessive Cooling
iii. Fire
iv. Flare or Flash

Level 4
2.
3.
4.
1.
1.
2.
3.
4.

Gas Leak
Gel Leak
Radiation Leak
Looping
Failure to ALign
Failure to Cut
Failure to Cycle
Failure to form Staple

1.
2.
1.
2.
3.
4.
5.
6.
7.
8.
9.

Failure to Osseointegrate
Loss Of Osseointegration
Difficult to Advance
Difficult to Inset
Difficult to Position
Difficult to Remove
Entrapment of Device or Device Component
Failure to Advance
Malposition of Device
Physical Resistance
Sticking

1.
2.
3.
4.
1.
2.
3.
4.
5.
6.
7.

Collapse
Difficult to Flold or Unfold
Difficult to Open or Close
Incomplete Coaptation
Migration od Device or Device Component
Unintended Arm Motion
Unintended Collision
Unintended Arm Motion
Unintended Head Motion
Unstable
Vibration

1. Misfocusing

1. Charred

Level 5
c. Strikethrough
a. Air Leak

a. Extrusion

10/28/2015

Level 6