FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3872644
·
Received May 23, 2014
Report
- Report Number
- 3008642652-2014-01592
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 22, 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 EVALUATION, THE BELT FAILED INCOMING FUNCTIONAL TESTING. INVESTIGATION REVEALED THERE WAS A SHORTED PULSE WIRE IN THE DISTRIBUTION NODE (DN) TO FRONT THERAPY ELECTRODE (TE) CABLE. THE ROOT CAUSE FOR THE SHORTED PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED PULSE WIRE. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. UPON SERVICING ELECTRODE BELT SN (B)(4), THE ELECTRODE BELT 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 |
|---|---|---|---|---|---|---|---|
| 307579 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |