MAUDE Adverse Event Report: RESMED LTD OBSOLETE S9 AUTOSET - RMD HC

Model Number 36125

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to resmed that a patient's oxygen saturation decreases to 84% during use of an s9 autoset device with supplemental oxygen.It was reported the patient's oxygen saturation did not decrease when placed on supplemental oxygen without the device.

Manufacturer Narrative

The s9 autoset device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.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 a patient's oxygen saturation decreases to 84% during use of an s9 autoset device with supplemental oxygen.It was reported the patient's oxygen saturation did not decrease when placed on supplemental oxygen without the device.

• Brand Name: OBSOLETE S9 AUTOSET - RMD HC
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9454888
• MDR Text Key: 170421987
• Report Number: 3004604967-2019-00450
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K091947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 36125
• Device Catalogue Number: 36125
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/13/2020
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1