MAUDE Adverse Event Report: RESMED CORPORATION CPAP AIRSENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Took my cpap to a local business and they made changes on the settings without an rx.Had to consult my (b)(4) company for help reverse adjustments.(b)(6).Fda safety report id# (b)(4).

• Brand Name: CPAP AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORPORATION
• MDR Report Key: 10282893
• MDR Text Key: 199447369
• Report Number: MW5095551
• 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
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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