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U.S. Department of Health and Human Services

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

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RESMED LTD AIRSENSE 10 AUTOSET USA TRI Back to Search Results
Model Number 37208
Device Problem Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)
Event Type  Injury  
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 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.

 
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 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.

 
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Brand NameAIRSENSE 10 AUTOSET USA TRI
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer (Section G)
RESMED CORP
9001 spectrum center blvd
san diego CA 92123
Manufacturer Contact
ariana beck
9001 spectrum center blvd
san diego, CA 92123
MDR Report Key7956435
MDR Text Key123401046
Report Number3004604967-2018-01483
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number37208
Device Catalogue Number37208
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/18/2018
Device Age16 mo
Event Location No Information
Date Manufacturer Received11/18/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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