MAUDE Adverse Event Report: RESMED PTY LTD. RESMED APNEALINK AIR; VENTILATORY EFFORT RECORDER

Model Number 22353

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  malfunction  

Event Description

Resmed apnealink air units have belt loops on the device that regularly break.The device is not useable without the belt loops.The breaks on the case can present sharp edges, which can harm patients during their sleep study.These devices often do not last 6 months in regular use.

• Brand Name: RESMED APNEALINK AIR
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESMED PTY LTD.
• MDR Report Key: 18486496
• MDR Text Key: 332903370
• Report Number: MW5150088
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/05/2024

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 Model Number: 22353
• Device Catalogue Number: 22353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1