FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2091440
·
Received May 6, 2011
Report
- Report Number
- 3002158293-2011-00517
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- March 24, 2011
- Report Date
- May 5, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK BELT/THERAPY PAD MESSAGES) HAS BEEN CONFIRMED. UPON EVAL THE ELECTRODE BELT CABLE WAS FOUND TO HAVE INTERNAL WIRE DAMAGE WITHIN THE A AND B ASSEMBLY. THE CAUSE FOR THE INTERNAL DAMAGE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT SERVICE TO REPORT CONSTANT ALARMS. 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 | 68 YR |