MAUDE Adverse Event Report: ACUTRONIC MEDICAL SYSTEMS AG MONSOON III; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	MONSOON III + HFJV UNIVERSAL UNIT
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any additional information received from the customer will be included in a follow-up report.The technical support attributed the reported issue to the defective main board.The main board was replaced with a new version (main-pcb rev 5.1).The fan was also replaced since it is necessary for new main board.Additionally, software was updated to v.2.071.
Event or Problem Description
The customer reported that the device experienced buzzer issues.At this time, there was no information provided regarding patient involvement in this event.

• Brand Name: MONSOON III
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ACUTRONIC MEDICAL SYSTEMS AG; fabrik im schiffli; hirzel, 8816 ; SZ 8816
• MDR Report Key: 9078237
• Report Number: 8031033-2019-00005
• Device Sequence Number: 14072917
• Product Code: CBK
• UDI-Device Identifier: 07640140861616
• UDI-Public: (01)07640140861616
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MONSOON III + HFJV UNIVERSAL UNIT
• Device Catalogue Number: 7700.US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1