FDA Adverse Event
Malfunction
Summary report: N
MONSOON III
MDR report key: 20566760
·
Received October 30, 2024
Report
- Report Number
- 20566760
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Date of Event
- May 13, 2024
- Report Date
- August 19, 2024
- Manufacturer
- ACUTRONIC MEDICAL SYSTEMS AG
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
JET VENT POWERED DOWN DURING A CASE AND KEPT DEFAULTING TO ANOTHER LANGUAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1781143 | MONSOON III | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | ACUTRONIC MEDICAL SYSTEMS AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |