FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3012657
·
Received February 22, 2013
Report
- Report Number
- 3008642652-2013-00510
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 22, 2013
- Report Date
- February 15, 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: DEVICE EVAL OF MONITOR SN (B)(4), HAS BEEN COMPLETED. UPON EVAL THE MONITOR'S FRONT RESPONSE BUTTON WAS NON-FUNCTIONAL, WHICH PREVENTED THE MONITOR FROM POWERING UP PAST THE SPLASH SCREEN. THE ROOT CAUSE FOR THE DEFECTIVE FRONT RESPONSE BUTTON COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PT 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, THE FRONT RESPONSE BUTTON ON MONITOR SN (B)(4), WAS NON-FUNCTIONAL. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78763 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |