FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 6420875
·
Received March 21, 2017
Report
- Report Number
- 3008642652-2017-02302
- Event Type
- Malfunction
- Date Received
- March 21, 2017
- Date of Event
- February 8, 2017
- Report Date
- March 21, 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 ("ADJUST BELT" AND "CHECK THERAPY PAD" MESSAGES). UPON INVESTIGATION, THE ELECTRODE BELT FAILED A TE RECOGNITION TEST. THE REAR THERAPY ELECTRODE PULSE WIRE SOLDER JOINT IN THE DISTRIBUTION NODE (DN) WAS BROKEN. THE ROOT CAUSE FOR BROKEN SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS CAUSING EXCESSIVE "ADJUST BELT" AND "CHECK THERAPY PAD" MESSAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202892 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |