FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYS
MDR report key: 3761149
·
Received December 31, 2013
Report
- Report Number
- 3008642652-2013-03751
- Event Type
- Malfunction
- Date Received
- December 31, 2013
- Date of Event
- December 4, 2013
- Report Date
- December 31, 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CHARGER/MODEM WOULD INTERMITTENTLY NOT RECOGNIZE A BATTERY PACK AND INTERMITTENTLY CHARGE A BATTER PACK. THE CAUSE FOR THE INABILITY TO CHARGE A BATTERY PACK WAS A DEFECTIVE U13 (8-BIT CMOS FLASH MICRO-CONTROLLER) COMPONENT. THE ROOT CAUSE OF THE DEFECTIVE U13 COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U13 COMPONENT. THE LAST PT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. DURING SERVICING, CHARGER/MODEM SN (B)(4) WOULD INTERMITTENTLY NOT RECOGNIZE A BATTERY PACK. THE LAST PT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682612 | LIFEVEST WCD 4000 SYS | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |