MAUDE Adverse Event Report: RESMED PTY LTD OBSOLETE S9 AUTOSET PLUS H5I - AMERICAS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 36015

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2023

Event Type  Death  

Manufacturer Narrative

An investigation will be performed on all available information based on reporter's obligations under applicable fda regulations; however, it is likely that this matter may become the subject of litigation which may limit the company¿s ability to disclose confidential, privileged attorney client communications and work product.Investigation methods, results and conclusions are not finalized at this stage partly because the device in question has not been returned for inspection and the fire scene investigation is currently on-going.If more information becomes available, a supplemental report will be submitted.Resmed reference #: (b)(4).

Event Description

On may 16, 2023 and on may 17, 2023, resmed received notifications in which lawyers alleged that several patients sustained injuries, with some patients sustaining fatal injuries, as a result of a fire incident that occurred on (b)(6) 2023.Packaging for resmed slimline tubing was found in the debris of the fire scene.The notice provided information that the product allegedly involved in the incident may be a resmed cpap device, however, the exact product brand and model of the device are currently unknown.

Manufacturer Narrative

The complaint device was not returned to resmed for investigation, but was inspected at the fire scene and laboratory examination by a third-party investigator expert from exponent.The reported complaint was not confirmed based on the inspection findings by a third-party investigator as there is no evidence indicating the fire originated from the cpap device nor its power supply.Based on all available evidence, the investigation determined the reported incident was not caused by resmed devices.Information of people involved in event: injured - (b)(6) female.Injured - (b)(6) male.Death - (b)(6) female 78 y/o dob (b)(6) 1944 race: black.Death - (b)(6) male 59 y/o dob (b)(6) 1963 race: black.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference #: (b)(4).

Event Description

On may 16, 2023 and on may 17, 2023, resmed received notifications in which lawyers alleged that several people sustained injuries, with some people sustaining fatal injuries, as a result of a fire incident that occurred on (b)(6) 2023.One of the people who expired was using an unknown sleep apnea device (cpap).The cpap was heavily damaged in the fire so the manufacturer was not clearly identified.However, packaging for resmed slimline tubing was found in the debris of the fire scene.The notice provided information that the product allegedly involved in the incident may be a resmed cpap device.Later, joint fire investigation revealed that the cpap is likely a resmed s9 cpap with an h5i humidifier.

• Brand Name: OBSOLETE S9 AUTOSET PLUS H5I - AMERICAS
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17115775
• MDR Text Key: 317025052
• Report Number: 3007573469-2023-00399
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 36015
• Device Catalogue Number: 36015
• Device Lot Number: 1322641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2024
• Distributor Facility Aware Date: 01/31/2024
• Event Location: Other
• Date Report to Manufacturer: 02/28/2024
• Date Manufacturer Received: 01/31/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death