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

Model Number PESON2 M-I

Device Problem Device Tipped Over (2589)

Patient Problems Aspiration/Inhalation (1725); Choking (2464)

Event Date 09/26/2019

Event Type  Injury  

Event Description

In april, i received the resmed airsense 10 autoset pap device as a replacement for one i had for over five years.In mid-spring and then, again, last thursday night, while i was sleeping, the device tipped over.As a result, water in the reservoir flowed directly into the tubing which connects the device to the face mask.The air pressure then forced the water up the tubing and into my nose, while i was breathing.I aspirated the water and began choking.During the first incident, i was able to commence normal breathing rather quickly.On thursday's event, my choking was quite bad and it took a long time for me to be able to breathe.The base of the device is smaller than the body.As a result, when the tubing is tugged, the device has a tendency to tip over.Most likely, the tugging of the tubing occurs when i toss and turn while sleeping.I had never had a problem such as this with the prior device.When i discussed this problem with the provider, i was told the solution was to not put any water in the reservoir.This, of course, defeats the purpose of providing a humid flow of air; caused me to choke.Fda safety report id# (b)(4).

• Brand Name: RESMED AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 9145249
• MDR Text Key: 161033468
• Report Number: MW5090135
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498370283
• UDI-Public: 00619498370283
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PESON2 M-I
• Device Catalogue Number: 37028
• Device Lot Number: 1355397
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 88