FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2091446
·
Received May 6, 2011
Report
- Report Number
- 3002158293-2011-00526
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- March 5, 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 EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT CONNECTOR WAS BROKEN. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A REVIEW OF A (B)(6) FEMALE PATIENT'S DOWNLOAD REVEALED SEVERAL BELT FLAGS INCLUDING BELT INCOMPATABLE FLAGS, SERVICE CODE 204 AND GEL RELEASE FLAGS. THE PATIENT WAS CONTACTED BY ZOLL CUSTOMER SUPPORT AND 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 | 75 YR |