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

Model Number AIR SENSE 10

Device Problems Failure to Shut Off (2939); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2021

Event Type  malfunction  

Event Description

Wake up at least 2 times per night.Sometimes machine is off and not working.Sometimes machine does not turn off when i remove the mask.Previously used so clean machine.Have not used so clean in over a year.Recently told by provider not to use so clean machine.Resmed air sense 10 cpap machine purchased (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: RESMED AIR SENSE 10 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 12751118
• MDR Text Key: 280511331
• Report Number: MW5105123
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 11/01/2021
• 2 Devices were Involved in the Event: 1 2

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: AIR SENSE 10
• Device Catalogue Number: 37028
• Device Lot Number: 1371114
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Patient Sequence Number: 1
• Treatment: "EXTRA EXTRA BREAST IMPLANTS"; ATORVASTATIN; CALICIUM CITRATE+D3 ; LEVOTHYROXINE; META MUCIL; MOMETASONE FUROSTE; OLMESARTAN MEDOXOMIL
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White