FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2033475
·
Received March 23, 2011
Report
- Report Number
- 3002158293-2011-00334
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 16, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS CRACKED. THE ROOT CAUSE FOR THE CRACKED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. ONCE THE TRUNK WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
ZOLL CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF A (B)(6) FEMALE PATIENT WHICH REVEALED A SERVICE CODE 204. THE PATIENT WAS ISSUED 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 | 47 YR |