FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4031080
·
Received July 17, 2014
Report
- Report Number
- 3008642652-2014-02252
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Date of Event
- June 17, 2014
- Report Date
- July 15, 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 MONITOR SN (B)(4) IS UNDERWAY. AS RECEIVED THE MONITOR WAS RESETTING. A ROOT CAUSE INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL MDR WILL BE SENT UPON COMPLETION OF ROOT CAUSE INVESTIGATION. 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, MONITOR SN (B)(4) WAS RESETTING. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420634 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |