FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 1884595
·
Received October 25, 2010
Report
- Report Number
- 3002158293-2010-01094
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- July 7, 2010
- Report Date
- October 21, 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 BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. DURING SERVICE INVESTIGATION, IT WAS DISCOVERED THAT THE CAUSE OF THE CHARGER MALFUNCTION WAS A DEFECTIVE COMPONENT (Q1). Q1 IS THE CURRENT CONTROLLING COMPONENT OF THE BATTERY CHARGER. THE ROOT CAUSE OF THE DEFECTIVE Q1 CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.
Description of Event or Problem · 1
A (B)(6) OLD MALE PATIENT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT BOTH BATTERIES ARE DISPLAYING THE BATTERY FAULT LIGHT WHEN PLACED ON THE CHARGER. THE PATIENT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |