FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 7222927
·
Received January 26, 2018
Report
- Report Number
- 3008642652-2018-00999
- Event Type
- Malfunction
- Date Received
- January 26, 2018
- Date of Event
- December 29, 2017
- Report Date
- January 24, 2018
- 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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED. UPON EVALUATION THE MONITOR RESET AFTER DELIVERING A PULSE DURING A PULSE TEST. THE ROOT CAUSE FOR THE RESET WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON (B)(4) 2015. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A MONITOR WAS RESETTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65649 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |