FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1821426
·
Received August 26, 2010
Report
- Report Number
- 3002158293-2010-00889
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 25, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE FOR THE BROKEN ELECTRODE BELT WAS A BROKEN TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE BROKEN CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE IS GETTING A MESSAGE TO CONNECT THE ELECTRODE BELT WITH THE MONITOR. WHEN THE BELT WAS CONNECTED, A SERVICE CODE 105 WAS ON THE SCREEN. THE PT'S ELECTRODE BELT WAS REPLACED.
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 | 50 YR |