FDA Adverse Event
Malfunction
Summary report: N
MONSOON III
MDR report key: 9079601
·
Received September 17, 2019
Report
- Report Number
- 8031033-2019-00006
- Event Type
- Malfunction
- Date Received
- September 17, 2019
- Date of Event
- May 11, 2018
- Report Date
- May 11, 2018
- Manufacturer
- ACUTRONIC MEDICAL SYSTEMS AG
- Product Code
- CBK
- PMA / PMN Number
- K012691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE MOTHERBOARD WAS REPLACED ON THE DEVICE AND THE SOFTWARE WAS UPDATED FROM V.2.03 TO V.2.071. ADDITIONALLY, THE FLAT GASKET OF THE CALIBRATION VALVE WAS REPLACED. THE CUSTOMER REPORTED THAT THE DEVICE ISSUE WAS RESOLVED THEREAFTER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE EXPERIENCED THE "OXYGEN SENSOR WEAK" ALARM AND THE "FIO2 ERROR". AT THIS TIME, THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT INVOLVEMENT IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870775 | MONSOON III | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | ACUTRONIC MEDICAL SYSTEMS AG | MONSOON III + SHFJV UNIVERSAL UNIT +ETCO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |