FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2954299
·
Received January 9, 2013
Report
- Report Number
- 3008642652-2013-00098
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 10, 2012
- Report Date
- January 9, 2013
- 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVAL THE MONITOR WOULD NOT POWER UP. THE CAUSE FOR THE INABILITY TO POWER ON WAS ISOLATED TO EXTENSIVE INTERNAL CONTAMINATION IN THE MONITOR. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, MONITOR SN (B)(4) WOULD NOT POWER UP. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11274 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |