FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 2911261
·
Received December 14, 2012
Report
- Report Number
- 3008642652-2012-03259
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 25, 2012
- Report Date
- December 7, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEFECTIVE RESPONSE BUTTONS) HAS BEEN CONFIRMED. UPON RECEIPT, THE REAR RESPONSE BUTTON CABLE CONNECTOR WAS DEFECTIVE AND WAS UNABLE TO STAY CONNECTED. THE ROOT CAUSE FOR THE DEFECTIVE RESPONSE BUTTON CABLE CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE PT WAS ISSUED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
(B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR'S RESPONSE BUTTONS WOULD NOT ACTIVATE THE DEVICE. THE PT WAS ISSUED 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 | 40 YR |