FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 3974890
·
Received June 11, 2014
Report
- Report Number
- 3008642652-2014-01804
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Date of Event
- May 12, 2014
- Report Date
- June 10, 2014
- Manufacturer
- ZOLL MANUFACTURING 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 SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO THE 318 AND #19 PINS IN THE TRUNK CABLE CONNECTOR BEING BENT OUT OF POSITION. THE ROOT CAUSE FOR THE BENT PINS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PT 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. DURING SERVICING, ELECTRODE BELT SN (B)(4) FAILED INCOMING FUNCTIONALITY TESTING. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343820 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |