FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3812664
·
Received April 25, 2014
Report
- Report Number
- 3008642652-2014-01231
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 19, 2014
- Report Date
- April 18, 2014
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER POWER CONNECTOR PROBLEM) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE POWER SUPPLY CONNECTOR WAS BENT WHICH PREVENTED THE POWER SUPPLY FROM CONNECTING TO AND POWERING ON THE CHARGER. THE ROOT CAUSE OF THE BENT CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM DEFECTIVE POWER SUPPLY BRICK CONNECTOR. THE PT REC'D A REPLACEMENT BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PRONGS ON HER BATTERY CHARGER CONNECTOR WERE BENT. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251375 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |