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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED CORP. RESMED AIRSENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESMED CORP. RESMED AIRSENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 37028
Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)
Patient Problem Dyspnea (1816)
Event Date 04/09/2022
Event Type  malfunction  
Event Description
Approximately 15-20 minutes after turning my resmed airsense 10 on, the units air pressure turns off abruptly and i'm left gasping for air.An error is displayed on the screen: "attention.Tubing blocked, check your tubing".The tubing is not blocked at all, the air filter is clean and there is no interruption of power to the unit.I've read online that there is a dangerous software bug in this product and i've read that others are experiencing the same issue where they are left gasping for air because their machine shuts off automatically in the middle of the night for no reason.I'm afraid to use my cpap device and gave discontinued use.Fda safety report id # (b)(4).
 
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Brand Name
RESMED AIRSENSE 10
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESMED CORP.
MDR Report Key14111823
MDR Text Key289349427
Report NumberMW5108990
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number37028
Device Catalogue Number37028
Device Lot Number1126318
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
LOSARTAN
Patient Outcome(s) Other;
Patient Age53 YR
Patient SexMale
Patient Weight100 KG
Patient EthnicityHispanic
Patient RaceWhite, American Indian Or Alaskan Native
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