FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3210055
·
Received June 27, 2013
Report
- Report Number
- 3008642652-2013-01697
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 25, 2013
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM HAD 0F04 CHARGER FAULTS. THE CAUSE FOR THE FAULTS WAS ISOLATED TO A CORRUPTED U13 8-BIT CMOS MICROCONTROLLER. THE ROOT CAUSE FOR THE CORRUPTED U13 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U13 COMPONENT. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY PACKS WEREN'T PROPERLY RECHARGING. DOWNLOAD DATA REVEALED SEVERAL CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292330 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |