MAUDE Adverse Event Report: RESMED LTD S8 AUTOSET SPIRIT - EUR G1

Model Number 33113

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

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).Pending evaluation.

Event Description

It was allegedly reported to resmed that an s8 autoset device caught fire.There were no reports of a serious injury or any kind of medical attention sought by the patient.

Event Description

It was allegedly reported to resmed that an s8 autoset device caught fire.There were no reports of a serious injury or any kind of medical attention sought by the patient.

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the root cause was mechanical deterioration of the ac appliance inlet connector solder joint in the power supply unit.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: S8 AUTOSET SPIRIT - EUR G1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11058273
• MDR Text Key: 223717037
• Report Number: 3004604967-2020-01236
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K041209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33113
• Device Catalogue Number: 33113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Distributor Facility Aware Date: 12/21/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1