MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET USA TRI

Model Number	37208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pneumonia (2011)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.If the device is returned, resmed will supplement this report.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that a patient was found with bloody emesis and distended abdomen while using an airsense 10 autoset device with quattro fx ffm large.Patient was taken to the hospital and underwent exploratory abdominal surgery which reportedly found compressed air in the stomach and bowels.Surgeon determined the patient had aspiration pneumonia.Patient has discontinued cpap therapy.Resmed has not examined device.Patient's wife reported the device went rogue.
Additional Manufacturer Narrative
The airsense 10 autoset device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.A clinical opinion has been supplied based on therapy data, and concluded that there is insufficient evidence to suggest that the patient¿s injury was caused or contributed to by the device or the device¿s ability to effectively deliver therapy.Resmed's risk analysis for the use of this device remains unchanged and acceptable.(b)(4).
Event or Problem Description
It was reported to resmed that a patient was found with bloody emesis and distended abdomen while using an airsense 10 autoset device with quattro fx ffm large.Patient was taken to the hospital and underwent exploratory abdominal surgery which reportedly found compressed air in the stomach and bowels.Surgeon determined the patient had aspiration pneumonia.Patient has discontinued cpap therapy.Resmed has not examined device.Patient's wife reported the device went rogue.

• Brand Name: AIRSENSE 10 AUTOSET USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 7956435
• Report Number: 3004604967-2018-01483
• Device Sequence Number: 930931
• Product Code: CBK
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1246777
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Distributor Facility Aware Date: 11/18/2018
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/18/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 122