FDA Adverse Event
Death
Summary report: N
FR3 DEFIB, ECG US ENGLISH (T) EXCHANGE
MDR report key: 11810819
·
Received May 12, 2021
Report
- Report Number
- 3030677-2021-11422
- Event Type
- Death
- Date Received
- May 12, 2021
- Date of Event
- April 27, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- UDI-DI
- 00884838049994
- PMA / PMN Number
- P160028
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DURING A PATIENT USE EVENT, THE DEVICE GAVE "ANALYSIS INTERRUPTED" PROMPTS DURING THE ANALYSIS PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711593 | FR3 DEFIB, ECG US ENGLISH (T) EXCHANGE | AED | MKJ | PHILIPS NORTH AMERICA LLC | 861389 | 00884838049994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |