FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3941554
·
Received April 17, 2014
Report
- Report Number
- 3008642652-2014-01168
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 22, 2014
- Report Date
- April 14, 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, BELT FAILED THE HIPOT TEST. THE CAUSE WAS ISOLATED TO THE TRUNK CABLE. THERE WAS A SHORT INSIDE THE TRUNK CABLE, WHICH CAUSED THE TEST FAILURE. THE ROOT CAUSE OF THE SHORT WAS UNABLE TO BE POSITIVELY DETERMINED, BUT LIKELY PHYSICAL ABUSE AS THE TRUNK CABLE WAS CRACKED AS RECEIVED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) FAILED THE HIPOT TEST. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236147 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |