FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2885296
·
Received November 21, 2012
Report
- Report Number
- 3008642652-2012-03074
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 25, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ABNORMAL SHUTDOWNS) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON BOTH PCA BOARDS. THE CAUSE OF THE CONTAMINATION WAS CAPACITOR C19 LEAKING ELECTROLYTIC LIQUID ON BOTH CA BOARDS. THE ROOT CAUSE OF THE LEAKING CAPACITOR WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY CAUSED BY OVERCHARGING OR THE CAPACITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR MADE A POPPING NOISE AND WOULD NOT STAY POWERED ON. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |