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

Model Number AIR SENSE 10

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  Injury  

Event Description

Blow pressure greater than 30 psi.Could not use the respironics air sense 10.I had been using it more than four years.Testing by (b)(4).

• Brand Name: AIR SENSE 10 CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 12413896
• MDR Text Key: 270041146
• Report Number: MW5103682
• Device Sequence Number: 1
• Product Code: BZD
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 93