FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3904883
·
Received June 4, 2014
Report
- Report Number
- 3008642652-2014-01706
- Event Type
- Malfunction
- Date Received
- June 4, 2014
- Date of Event
- May 5, 2014
- Report Date
- June 2, 2014
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE REAR RESPONSE BUTTON WAS NON-FUNCTIONAL. THE CAUSE FOR THE DEFECTIVE RESPONSE BUTTON WAS ISOLATED TO A BROKEN RESPONSE BUTTON FLEX CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED RESPONSE BUTTON CABLE. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, THE REAR RESPONSE BUTTON OF MONITOR SN (B)(4) WAS DEFECTIVE. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327887 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |