FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1121033
·
Received August 14, 2008
Report
- Report Number
- 3002158293-2008-00364
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 2, 2008
- Report Date
- August 13, 2008
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS THAT THE MONITOR HAD A DEFECTIVE CAPACITOR BANK. THE MONITOR WOULD NOT HAVE TREATED IF NEEDED. THE ROOT CAUSE OF THE DEFECTIVE CAPACITOR BANK IS UNKNOWN, BUT IS LIKELY RANDOM COMPONENT FAILURE. THE MONITOR WILL BE REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PT REC'D A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A RECENT DOWNLOAD OF A MALE PT REVEALED SEVERAL "DISCHARGE PROFILE FAULT" FLAGS. LIFECOR CUSTOMER SUPPORT SENT THE PT A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |