FDA Adverse Event
Death
Summary report: N
BREAS VIVO 50
MDR report key: 11500590
·
Received March 17, 2021
Report
- Report Number
- 9617566-2019-00018
- Event Type
- Death
- Date Received
- March 17, 2021
- Date of Event
- July 14, 2019
- Report Date
- August 14, 2019
- Manufacturer
- BREAS MEDICAL AB
- Product Code
- NOU
- UDI-DI
- 00732182215005
- PMA / PMN Number
- K123144
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS SUBMISSION IS FOR CORRECTION OF MISSING FOLLOW UP REPORT. THIS IS FOLLOW-UP #1. NO OTHER NEW COMPLAINT INFORMATION HAS BEEN ADDED.
Description of Event or Problem · 1
HIGH PRESSURE ALARM AND HIGH ETCO2 ALARM WENT OFF CONTINUOSLY THAT APPEARS TO BE FOR A COUPLE HOURS ON END PER THE EVENT LOG. THE VENT WAS ALARMING AND FAMILY WENT INTO THE ROOM TO ASSESS THE SITUATION AND HIM LIFELESS IN THE BED. EMS WAS CALLED BUT HE WAS PRONOUNCED DEAD ON ARRIVAL. CORONER FOUND THAT THE PATIENT DIED OF NATURAL CAUSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401337 | BREAS VIVO 50 | RESPIRATORY THERAPY DEVICE (HOMECARE USE) | NOU | BREAS MEDICAL AB | BREAS VIVO 50 | 00732182215005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |