FDA Adverse Event
Malfunction
Summary report: N
HWD
MDR report key: 13825073
·
Received March 19, 2022
Report
- Report Number
- 3008642652-2022-02709
- Event Type
- Malfunction
- Date Received
- March 19, 2022
- Date of Event
- March 18, 2022
- Report Date
- March 18, 2022
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005173
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CJ 6.13
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12232 | HWD | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | HWD 1000 | 00855778005173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |