Medical Devices

Case Studies

A Case Study is an illustrated example used to work though particular scenarios and assist the reporter in understanding and achieving specific determinations. Certain device malfunction situations may be difficult to describe. Included below are some case examples to illustrate how one would determine the appropriate CDRH Event Problem Code in a given situation.

CDRH Event Problem Code Case Studies

Coding ScenarioFDA Code Historically usedSuggested FDA CodeReason for Change
Unable to find a code or codes that describe an adverse event.2203 - Other (for use when appropriate device or patient code cannot be identified)FDA 3191; C64343- No Code AvailableOther was overused and contributed to a lot of ‘noise’ in the adverse event reports. If ‘no code available’ is used, the expectation is that the reporter will fill out a change request to recommend a new problem code.
Difficult to select a code and be confident that it had the appropriate meaning. Selected term that made sense to reporter based upon own interpretation of what code meant because the term was too general.1047 - Back-up, failure toFDA 1047; C63195 – Failure to back-up (Parent: Data Back-up problem) OR
FDA 2983; C63039 – Mechanical Jam (Parent: Mechanical Issue)
The term failure to back-up was not previously defined and was not grouped with other terms in a way that would assist the reporter in understanding the meaning of the term. Reporters used the term to describe failing to back-up software as well as failing to back-up a wheelchair. The new hierarchy provides parent terms (more general terms), child terms (more specific terms) and definitions to assist in code selection.
Difficult to locate a unique device problem not associated with a component or difficult to find a combination of a device problem and component that describes the adverse event.

1049 - Balloon Rupture

Component Code: N/A

FDA 1546; C62965 - Material Rupture


Component Code: FDA 419; C49837 - Balloon

All codes that contained combinations of Device/Component Codes were inactivated. Component Codes previously included in a Device Problem Code were separated from Device Problem Codes to allow a reporter to identify a device issue with a particular problematic device component, or accessory. For example, if you wish to report that a balloon ruptured, select the Device Problem Code Material Rupture FDA 1546; C62965 and the Component Code, Balloon FDA 419; C49837 to distinguish between the device component and reported issue.
Use of the same word to describe a patient problem and a device problem.

1212 - Entrapment (Device Problem)


2327 – Entrapment

(Patient Problem)

FDA 1212; C63210 - Entrapment of Device or Device Component

FDA 2327; C50548 - Physical Entrapment

There is often confusion about what is a patient problem and what is a device problem. In this case, entrapment of device as a Device Problem Code indicates that a device and/or device accessory is caught in a patient. Entrapment as a Patient Problem Code indicates that a patient is entrapped by a device, i.e. bed rail. Definitions have been added to clarify such confusing terms.
There is a mixing of device problem codes with evaluation codes.1530 - ReplaceTerm InactivatedThis term was inactivated because it fails to demonstrate the device issue which occurred. The term Replace indicates an Evaluation Result. The Evaluation Codes are being evaluated to include such codes. Note that there are still some evaluation conclusion codes that remain in the device problem codes. These have been retained to allow User Facilities to report evaluation results to FDA because there is no other code where this can be reported. Evaluation codes from manufacturers are still considered to be the final evaluation of a device issue.
Codes with similar descriptions may now be under different parts of the hierarchy. Be sure to look throughout the hierarchy to pick the appropriate code.

1668 - Unwrap, difficult to


1669 - Unwrap, failure to

1668 was inactivated

Preferred Term: FDA 2940; C63154 - Failure to Unwrap (Parent - Difficult to Open or Remove Packaging Material)

FDA 1669; C62949 - Failure to Unfold or Unwrap (Parent – Material deformation)

Again, the hierarchy provides context for which term to select. These two similar codes are displayed in hierarchy under two different parent terms in order to capture whether the event was a packaging issue (FDA 2940; C63154) OR a device property issue inherent to the device (FDA 1669; C62949) versus. Failure to unwrap as a packaging issue would be an issue with the packaging/shipping process. Whereas if a device is supposed to unfold or unwrap after it is applied and it fails to do so, that would be considered material deformation.


Page Last Updated: 12/16/2014
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