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

Model Number	7700.US
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: acutronic support in conjunction with the customer determined the most likely cause of the event is the motherboard.Additional information was requested on whether or not the repairs will be done by distributor or acutronic.
Event or Problem Description
The customer reported that the monsoon ventilator alarmed with the following issues: peak inspiratory pressure (pip) measuring electronic error and driving (dp) measuring electronic errors.The issue occurred during patient use in adult double jet ventilation mode.The customer reported the error occurred twice during a twelve hour shift and was still in use.At this time, there is no known impact or consequence to the patient.

• Brand Name: MONSOON+
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ACUTRONIC MEDICAL SYSTEMS AG; fabrik im schiffli; hirzel, 8816 ; SZ 8816
• MDR Report Key: 8805622
• Report Number: 8031033-2019-00001
• Device Sequence Number: 13538868
• Product Code: CBK
• UDI-Device Identifier: 07640140861616
• UDI-Public: (01)07640140861616
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7700.US
• Device Catalogue Number: 7700.US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other