FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 8865925
·
Received August 6, 2019
Report
- Report Number
- 3008642652-2019-06035
- Event Type
- Malfunction
- Date Received
- August 6, 2019
- Date of Event
- June 18, 2019
- Report Date
- July 31, 2019
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005005
- 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CASE) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE MONITOR'S ELECTRODE BELT RECEPTACLE WAS BROKEN FREE FROM THE MONITOR ENCLOSURE, DAMAGING WIRES WITHIN THE CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A PATIENT'S MONITOR BELT RECEPTACLE WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661216 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |