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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED RESMED AIRSENSE 10 AUTOSET VENTILATOR, CONTINUOUS

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RESMED RESMED AIRSENSE 10 AUTOSET VENTILATOR, CONTINUOUS Back to Search Results
Device Problem Gas Leak (2946)
Patient Problems Aspiration/Inhalation (1725); Vomiting (2144); Abdominal Distention (2601)
Event Date 04/14/2018
Event Type  Injury  
Event Description

Per wife, pt was placed on cpap. Wife returned within two hours to find him with bloody emesis and a distended abdomen. Taken to hospital and underwent exploratory abdominal surgery which reportedly found compressed air in stomach and bowels which led to an aspiration event. Wife believes cpap machine went "rogue. ".

 
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Brand NameRESMED AIRSENSE 10 AUTOSET
Type of DeviceVENTILATOR, CONTINUOUS
Manufacturer (Section D)
RESMED
san diego CA 92123
MDR Report Key7809466
MDR Text Key118125538
Report NumberMW5079346
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/22/2018 Patient Sequence Number: 1
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