FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2033088
·
Received February 28, 2011
Report
- Report Number
- 3002158293-2011-00221
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 23, 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 (BELT COMMUNICATION FAULTS) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS BROKEN. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. THE BELT WAS FULLY FUNCTIONAL ONCE THE TRUNK WAS REPLACED. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A LOUD SIREN ALARM. A REVIEW OF THE PT'S DOWNLOAD REVEALED SEVERAL BELT COMMUNICATION FAULTS. THE PT 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 | 43 YR |