MAUDE Adverse Event Report: RESMED CORP. RESMED AIRSENSE 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Resmed cloud-based software airview appears to have a possible discrepancy in data reporting.For the airsense 11 positive airway pressure (pap) device, the humidifier settings in the remote assist tab/screen do not correlate with those reported in the prescription tab/screen or on the patient device.Fda safety report id# (b)(4).

• Brand Name: RESMED AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 13315196
• MDR Text Key: 284349797
• Report Number: MW5106854
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1