FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 1861248
·
Received October 1, 2010
Report
- Report Number
- 3002158293-2010-01003
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- August 6, 2010
- Report Date
- October 1, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (MONITOR IS UNABLE TO POWER ON) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THIS MONITOR WOULD NOT POWER ON WITH EITHER BATTERY PACK. THE PT RECEIVED A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |