FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2081744
·
Received April 11, 2011
Report
- Report Number
- 3002158293-2011-00404
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 4, 2011
- Report Date
- April 8, 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 (CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS FOUND THAT A PULSE WIRE ON ECG B WAS NOT CONNECTED. THE CAUSE FOR THE DISCONNECTED PULSE WIRES CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF COLD SOLDERS. NO ADVERSE EVENT RESULTED FROM THE OPEN CONNECTION. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE IS RECEIVING CONSTANT CHECK BELT ALARMS. THE PT 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 | 79 YR |