FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4161400
·
Received July 23, 2014
Report
- Report Number
- 3008642652-2014-02311
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 27, 2014
- Report Date
- July 22, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS UNDERWAY. AS RECEIVED, THE BELT FAILED INCOMING HI-POT TESTING. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT.
Description of Event or Problem · 1
DURING SERVICING OF ELECTRODE BELT SN (B)(4) A REPORTABLE PROBLEM WAS FOUND. THE BELT FAILED INCOMING HI-POT TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430742 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |