FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 3180224
·
Received June 5, 2013
Report
- Report Number
- 3008642652-2013-01512
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Date of Event
- April 29, 2013
- Report Date
- June 4, 2013
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT BASELINE) HAS BEEN CONFIRMED. UPON RECEIPT THE ELECTRODE BELT WAS UNABLE TO BASELINE. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY IN ENGINEERING. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A ZOLL PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING A (B)(6) MALE PT TO REPORT THE INABILITY TO COMPLETE A BASELINE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249356 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |