FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2011953
·
Received February 14, 2011
Report
- Report Number
- 3002158293-2011-00161
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- January 3, 2011
- Report Date
- February 9, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CAN COMM TIMEOUTS) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE WAS FOUND TO BE INTERMITTENT. THE ROOT CAUSE FOR THE INTERMITTENT CONNECTION CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF PHYSICAL DAMAGE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE RECEIVED A SERVICE CODE 204. THE PATIENT'S DOWNLOAD REVEALED SEVERAL CAN COMM TIME-OUTS. THE PATIENT WAS ISSUED 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 | 57 YR |