FDA Adverse Event
Malfunction
Summary report: N
MONSOON III
MDR report key: 6770103
·
Received August 7, 2017
Report
- Report Number
- 8031033-2017-00001
- Event Type
- Malfunction
- Date Received
- August 7, 2017
- Date of Event
- June 7, 2017
- Report Date
- July 27, 2017
- Manufacturer
- ACUTRONIC MEDICAL SYSTEMS AG
- Product Code
- CBK
- PMA / PMN Number
- K012691
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE USER: COULD NOT CHANGE THE FIO2 FROM 70% TO 100%. I STOPPED THE MONSOON AND STARTED IT AGAIN, BUT IT 'FROZE' AND WOULD NOT RESTART. THE PATIENT BECAME HYPOXIC AND WE HAD TO CHANGE TO ANAESTHETIC MACHINE VENTILATION AS AN EMERGENCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551228 | MONSOON III | JET VENTILATOR | CBK | ACUTRONIC MEDICAL SYSTEMS AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |