MAUDE Adverse Event Report: RESMED CORP. AIRSENSE 10 AUTOSET FOR HER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37036

Device Problem Device Alarm System (1012)

Patient Problems High Blood Pressure/ Hypertension (1908); Sleep Dysfunction (2517)

Event Date 12/18/2018

Event Type  Injury  

Event Description

Around (b)(6) 2018 machine started stopping and displayed error message saying tubing was blockage.Could not find blockage and machine would restart with no charges and come back up to pressure, so i did not consider that serious.I generally cannot sleep without pap therapy so i felt if it stopped i would wake up and restart it.But i¿m not sure i am waking up with every occurrence and my blood pressure readings have increased (it had been high prior to starting pap therapy in 2009 but was resolved with that treatment).Tried replacing related accessories, including heated hose, mask, filter, and humidifier chamber, which seemed to have no effect.I started to notice around the same time that usage hours displayed on the machine and via resmed myair software were less than actually used.Seemed to correlate with stoppage time, i.E.If stopped after hour of use only that hour of usage would be displayed.Started looking at details with 3rd party software.The problem(s) seems to have significantly increased in frequency since (b)(6).I have had a change of insurance during this time and my durablem medical equipment provider may have changed, my sleep specialist physician¿s assistant left the practice, and i may have to change to a different practice due to the insurance change.Appointments with sleep specialists are currently backlogged about 4 months here in (b)(6).My previous durable medical equipment provider is horrible, they could not even properly dispense a chin strap, i would never want them to make any repair or adjustment to my pap equipment.I reviewed patient discussions of these issues online and it appears to have been reported starting in 2015 or 2016 and was supposedly via a firmware software update.It was my understanding such updates were delivered over the air as the airsense 10 has wireless connectivity.I would like to verify that my equipment has this update directly as i do not want to deal with the totally incompetent dme provider who originally dispensed this equipment.I would also like confirmation that corrective action was effective.I would like assistance directly from the manufacturer with corrections and corrective actions that i might be able to do myself with the assistance of a technical representative.I am willing to work with a dme only for the purpose of returning the equipment to the manufacturer or a repair facility appropriately authorized by the manufacturer.I consider the second issue potentially life threatening because resmed has been reported to share myair data with insurers, and my sleep specialist definitely reviews the data to include compliance (usage over 4 hours each night).See (b)(4).If the incorrect usage data is being shared with my insurer, i may not be considered compliant and may not be able to obtain repair or a replacement device.I've requested blood pressure readings from doctors visits going back a year to see if there is a trend upward detected in correlation with device issues.Hypertension medication was started (b)(6) 2018.Can provide some detailed usage data from 3rd party software, and long term summary data from myair, if needed.

• Brand Name: AIRSENSE 10 AUTOSET FOR HER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 8189841
• MDR Text Key: 131466327
• Report Number: MW5082410
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/19/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37036
• Device Catalogue Number: 37036
• Device Lot Number: 991358
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 98