FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 3940376
·
Received April 17, 2014
Report
- Report Number
- 3008642652-2014-01148
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 10, 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 HOUSING WAS BROKEN. THE CONNECTOR LOCKING NUT WAS DAMAGED WHICH WOULD PREVENT THE ELECTRODE BELT FROM PROPERLY SECURING INTO THE MONITOR. THE ROOT CAUSE FOR THE DAMAGED LOCKING NUT CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. PATIENT WAS RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
DURING INVESTIGATION INTO A (B)(6) FEMALE PT'S ELECTRODE BELT, WHICH WAS RETURNED FOR UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT CONNECTOR LOCKING NUT WAS CRACKED. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235604 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |