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

Model Number 33113

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).

Event Description

It was allegedly reported to resmed that an s8 device caught fire.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The s8 device was returned to resmed for an investigation.Visual inspection of the device revealed thermal damage.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to failure of ac connector¿s flying leads connected to the power main circuit board.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was allegedly reported to resmed that an s8 device caught fire.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: S8 AUTOSET SPIRIT - EUR G1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 13596132
• MDR Text Key: 289011569
• Report Number: 3004604967-2022-00114
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K013843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2022
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1