FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1913026
·
Received November 18, 2010
Report
- Report Number
- 3002158293-2010-01210
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 27, 2010
- Report Date
- November 11, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS REC'D, THE REAR THERAPY ELECTRODE PAD STRAIN RELIEF WAS TORN AT THE DISTRIBUTION NODE. THE ROOT CAUSE OF THE DAMAGED STRAIN RELIEF CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
DURING THE INVESTIGATION OF ELECTRODE BELT (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PRODUCT PROBLEM WAS DISCOVERED. THE ELECTRODE BELT WAS FOUND TO HAVE THE REAR THERAPY ELECTRODE PAD STRAIN RELIEF TORN AT THE DISTRIBUTION NODE. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |