FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3830420
·
Received May 14, 2014
Report
- Report Number
- 3008642652-2014-01456
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- April 18, 2014
- Report Date
- May 12, 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. UPON INVESTIGATION, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE WHITE PULSE WIRE IN THE TRUNK CABLE WAS OPEN. THE TRUNK CABLE SHOWED SINGS OF PHYSICAL ABUSE. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE CONNECTOR. 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 DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BELT SN (B)(4) FAILED INCOMING FUNCTIONAL TESTING. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287911 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |