FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2842218
·
Received November 12, 2012
Report
- Report Number
- 3008642652-2012-02974
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 6, 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 SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BELT FAILED THE INCOMING HI-POT TEST. THE CAUSE OF THE TEST FAILURE IS AN OPEN BLACK (MAIN BATT) WIRE IN THE TRUNK CABLE. THE CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES. (B)(4).
Description of Event or Problem · 1
REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, BELT SN (B)(4) FAILED THE HI-POT TEST. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |