MAUDE Adverse Event Report: RESMED LTD APNEALINK AIR-SERVICE DEVICE

Model Number 19897

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.(b)(4).

Event Description

It was reported to resmed that a technician sustained a burn when removing the battery from an apnealink air device.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.The reported complaint could not be confirmed.The investigation determined that there was no fault found with the returned device.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a technician sustained a burn when removing the battery from an apnealink air device.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: APNEALINK AIR-SERVICE DEVICE
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8617916
• MDR Text Key: 145380368
• Report Number: 3004604967-2019-00162
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• PMA/PMN Number: K143272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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: Lay User/Patient
• Device Model Number: 19897
• Device Catalogue Number: 19897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Distributor Facility Aware Date: 12/16/2019
• Device Age: 6 MO
• Date Report to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1