FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 6555268
·
Received May 9, 2017
Report
- Report Number
- 3008642652-2017-03851
- Event Type
- Malfunction
- Date Received
- May 9, 2017
- Date of Event
- April 10, 2017
- Report Date
- May 8, 2017
- 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 (ECG'S NON-FUNCTIONAL) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED OT A SEVERED BLUE (+5V) WIRE IN THE ECG "A&B" CABLE. THE ROOT CAUSE FOR THE SEVERED WIRE 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 THE ECG ELECTRODES WERE NON-FUNCTIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337429 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |