FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3974833
·
Received June 11, 2014
Report
- Report Number
- 3008642652-2014-01795
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Date of Event
- May 15, 2014
- Report Date
- June 9, 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 MONITOR SN (B)(4) IS UNDERWAY. UPON EVALUATION, THE MONITOR RESET DURING A PULSE TEST. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MONITOR INVESTIGATION. 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) RESET DURING A PULSE TEST. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343809 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |