FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2241630
·
Received September 2, 2011
Report
- Report Number
- 3008642652-2011-00573
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- July 30, 2011
- Report Date
- September 1, 2011
- 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CAN COMM TIMEOUTS) WAS CONFIRMED. UPON EVAL THE TRUNK CABLE CONNECTOR WAS SEVERED AND WIRES WERE EXPOSED. THE CAUSE FOR THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
AFTER REVIEWING DOWNLOAD DATA OF A (B)(6) FEMALE PT, ZOLL CUSTOMER SUPPORT DISCOVERED "CAN COMM TIMEOUT" ERRORS. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.
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 | 62 YR |