FDA Adverse Event
Death
Summary report: N
FR3 DEFIBRILLATOR, TEXT, EU, EXCHANGE
MDR report key: 11748177
·
Received April 29, 2021
Report
- Report Number
- 3030677-2021-11256
- Event Type
- Death
- Date Received
- April 29, 2021
- Date of Event
- April 18, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- UDI-DI
- 00884838049987
- PMA / PMN Number
- P160028
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
UPDATED AWARENESS DATE.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TWO DEVICES WERE INVOLVED IN THIS PATIENT USE CASE. A HS1 DEVICE (SERIAL NUMBER (B)(4)) ON THE EMERGENCY CART WAS NOT AVAILABLE FOR USE WHEN NEEDED AS THE DEVICE DID NOT HAVE A BATTERY OR PADS WITH IT. THE USER IS REPORTING THE FR3 DEVICE (SERIAL NUMBER (B)(4)) DID NOT SHOCK WHILE IN MANUAL MODE DURING A PATIENT USE EVENT. THE PATIENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640819 | FR3 DEFIBRILLATOR, TEXT, EU, EXCHANGE | AED | MKJ | PHILIPS NORTH AMERICA LLC | 861388 | 00884838049987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |