FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 6182781
·
Received December 16, 2016
Report
- Report Number
- 3008642652-2016-09307
- Event Type
- Malfunction
- Date Received
- December 16, 2016
- Date of Event
- November 11, 2016
- Report Date
- December 16, 2016
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM ("CHECK THERAPY PAD" AND "ADJUST BELT" MESSAGES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING FUNCTIONALITY TESTING, SPECIFICALLY A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE "CHECK THERAPY PAD" AND "ADJUST BELT" MESSAGES AND THE TEST FAILURE WAS ISOLATED TO AN OPEN PULSE WIRE IN THE TRUNK CABLE. THE ROOT CAUSE FOR THE OPEN WIRE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT A PATIENT WAS RECEIVING "CHECK THERAPY PAD" AND "ADJUST BELT" MESSAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833817 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |