FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2232944
·
Received July 21, 2011
Report
- Report Number
- 3008642652-2011-00272
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- May 15, 2011
- Report Date
- July 20, 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. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
DURING THE INVESTIGATION OF ELECTRODE BELT SN (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PROBLEM WAS DETECTED DURING SERVICING. THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE PATIENT 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 | 84 YR |