FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 6039336
·
Received October 19, 2016
Report
- Report Number
- 3008642652-2016-07586
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Date of Event
- September 8, 2016
- Report Date
- October 17, 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT GONG ALARMS) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED THE INCOMING THERAPY ELECTRODE (TE) RECOGNITION TEST. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE IN THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND FRONT TE, BETWEEN THE FRONT TE AND ECG ELECTRODE A. THE CAUSE OF THE CONSTANT GONG ALARMS IS THE OPEN WIRE. THE ROOT CAUSE OF THE OPEN WIRE IS EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT'S DEVICE WAS PRODUCING CONSTANT GONG ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690116 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |