MAUDE Adverse Event Report: RESMED CORP RESMED AIRSENSE11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRSENSE11

Patient Problem Discomfort (2330)

Event Date 12/29/2023

Event Type  malfunction  

Event Description

Resmed has a serious issue with the resmed airsense11 cpap.I am a respiratory therapist which delivers those machines to pts that suffer from sleep apnea.Too many of these machines have a ¿heater system error fault¿ that prevents the humidification of air pressure causing discomfort to the patients.Resmed has been aware of this problem for over 6 months and has done nothing but continue to distribute these defective cpaps to the dmes for distribution to the public.Resmed has not made this fault known to the prescribing physicians resulting in physicians continued orders for these defective devices.Resmed has issued no recall, no bulletin, nothing.They just keep telling the dme to continue to let them know when this happens and they will honor the warranty.Many cpaps with this fault will continue to go out to the public undetected.This has been ongoing for over 6 months.

• Brand Name: RESMED AIRSENSE11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 19115735
• MDR Text Key: 340397313
• Report Number: MW5153868
• 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: Unknown
• Type of Report: Initial
• Report Date: 04/03/2024

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: AIRSENSE11
• Device Lot Number: 1717577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1