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

Device Problem Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 my father went to sleep at around 9pm with his resmed aircurve 10 cpap device on.At around 2am he woke up coughing and said that the air coming from the hose of his cpap machine smelled strongly of burnt wires.The smoky smell stayed in his nostrils for several days.He has had a raspy voice and hacking cough since the issue occurred.On (b)(6) 2022 he took the cpap unit to the retailer that he got it from and was initially told to just take it home and wash the hoses and keep using it.He told them "hell no, the thing is full of smoke".The retailer then took the machine and said they would send it in for repairs.The retailer is: (b)(6).The serial # of the resmed aircurve 10 cpap unit is: (b)(4).While he was returning the device, he asked about seeing the doctor to make sure his lungs were okay.He said that the lady laughed at him and said "what is the doctor going to do?".I am his son, and first found out about all of this on (b)(6) 2022.I called the manufacturer's (resmed) consumer support number (b)(4) on (b)(6) 2022 to make them aware of the problem and see if they could send him for a medical exam to check if the smoke had caused any problems to his lungs.They told me to contact the local retailer regarding the problem with the machine; and just ignored the medical exam request.I called the west bend retailer to track where the machine was currently ((b)(6) 2022).They said i would have to call their corporate office at (b)(6) which i did ((b)(6) 2022).The corporate office forwarded me to a voicemail which said it would call me back within 24 hours.I will update this info if i hear back from them.Fda safety report id #:(b)(4).

• Brand Name: RESMED AIRCURVE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 14043266
• MDR Text Key: 289056679
• Report Number: MW5108815
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male