FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 7014125
·
Received November 9, 2017
Report
- Report Number
- 3008642652-2017-09374
- Event Type
- Malfunction
- Date Received
- November 9, 2017
- Date of Event
- September 25, 2017
- Report Date
- November 8, 2017
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005012
- 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 (SERVICE CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE WAS PULLED FROM THE STRAIN RELIEF, PULLING THE TRUNK CABLE'S JST CONNECTOR FROM CONNECTOR J702 ON THE DISTRIBUTION NODE PCA. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR RETURNED AN ELECTRODE BELT AND REPORTED THAT A PATIENT WAS RECEIVING A SERVICE CODE 204 (BELT UNUSABLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795371 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |