FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1951231
·
Received December 13, 2010
Report
- Report Number
- 3002158293-2010-01322
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 3, 2010
- Report Date
- December 10, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER ON) HAS BEEN CONFIRMED. THE CAUSE OF THE MONITOR NOT POWERING ON WAS DUE TO SEVERE LIQUID CONTAMINATION THROUGHOUT THE MONITOR. THE ROOT CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.
Description of Event or Problem · 1
THE WIFE OF A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR MAKES GURGLING NOISES AND THE RESPONSE BUTTONS FLICKER WHEN THE PT INSERTS A BATTERY. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.
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 | 52 YR |