FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYS
MDR report key: 3842530
·
Received February 21, 2014
Report
- Report Number
- 3008642652-2014-00488
- Event Type
- Malfunction
- Date Received
- February 21, 2014
- Date of Event
- February 10, 2014
- Report Date
- February 11, 2014
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WOULD NOT SECURELY CONNECT WITH THE MONITOR. THE CAUSE FOR THE INABILITY TO PROPERLY CONNECT WITH THE MONITOR IS A DEFECTIVE TRUNK CABLE CONNECTOR. THE ROOT CAUSE HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
DURING SERVICING OF A (B)(6) MALE PT'S ELECTRODE BELT, WHICH WAS RETURNED FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE TRUNK CABLE CONNECTOR WOULD NOT LATCH TO A TEST MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109434 | LIFEVEST WCD 4000 SYS | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |