MAUDE Adverse Event Report: RESMED LTD S9 VPAP ST - AM

Model Number 36008A

Device Problem No Audible Alarm (1019)

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

Event Date 09/16/2020

Event Type  Death  

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.The s9 vpap st is not intended to be used as a life support ventilator and an indicated patient would still be able to continue to breathe spontaneously.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that at the time a patient was found deceased while using an s9 vpap st, the s9 vpqp st was found not working, displaying please close h5i, flip lid attach tube and press any key on the screen, the lid of the h5i humidifier was not closed and there was no audible alarm.

• Brand Name: S9 VPAP ST - AM
• 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: 11904693
• MDR Text Key: 253453054
• Report Number: 3004604967-2021-00644
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 36008A
• Device Catalogue Number: 36008A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/28/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/28/2021
• Date Device Manufactured: 09/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR