FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2960369
·
Received January 11, 2013
Report
- Report Number
- 3008642652-2013-00131
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- December 12, 2012
- Report Date
- January 11, 2012
- 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 EVAL: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT, THE BELT FAILED THE PULSE LEAD HI-POT TEST AND THE TRUNK CABLE WAS CUT WITH WIRES EXPOSED. THE ROOT CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF ELECTRODE BELT SN (B)(4), THE ELECTRODE BELT FAILED THE PULSE LEAD HI-POT TEST. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17159 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |