FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1942883
·
Received December 23, 2010
Report
- Report Number
- 3002158293-2010-01355
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- November 16, 2010
- Report Date
- December 20, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO BASELINE) WAS CONFIRMED. UPON EVALUATION, THE BASELINE WAS FLAT ON BOTH CHANNELS. THE ROOT CAUSE OF THE INABILITY TO BASELINE WAS THE LACK OF DRIVEN GROUND SIGNAL, CAUSED BY A DEFECTIVE SOLDER CONNECTION ON ECG B. THIS SHORT CIRCUIT FROM THE SOLDER BRIDGE WOULD CAUSE THE BELT NOT TO RECOGNIZE A TREATABLE RHYTHM, AS THE BASELINE SIGNAL WOULD CONTAIN EXCESSIVE NOISE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A PT SERVICE REP CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS UNABLE TO BASELINE A PT. THE PSR RECEIVED A REPLACEMENT BELT TO FIT THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |