FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 2140339
·
Received June 15, 2011
Report
- Report Number
- 3008642652-2011-00056
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- May 12, 2011
- Report Date
- June 14, 2011
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE IS ALARMING) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE CABLE RUNNING FROM THE DISTRIBUTION NODE TO ECG B HAS AN OPEN INTERNAL WIRE. THE ROOT CAUSE OF THE OPEN INTERNAL WIRE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN INTERNAL WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE DEVICE IS ALARMING WITH BOTH GARMENTS ON. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |