FDA Adverse Event
Malfunction
Summary report: N
HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE
MDR report key: 11619890
·
Received April 6, 2021
Report
- Report Number
- 3030677-2021-10717
- Event Type
- Malfunction
- Date Received
- April 6, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- PMA / PMN Number
- P160029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520042 | HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE | AED | MKJ | PHILIPS NORTH AMERICA LLC | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |