OBSOLETE S9 AUTOSET - RMD HC 36125

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-11 for OBSOLETE S9 AUTOSET - RMD HC 36125 manufactured by Resmed Ltd.

Event Text Entries

[170421493] 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).
Patient Sequence No: 1, Text Type: N, H10


[170421554] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007573469-2019-00450
MDR Report Key9454885
Date Received2019-12-11
Date of Report2020-03-06
Date Facility Aware2020-02-13
Report Date2020-03-06
Date Reported to FDA2020-03-06
Date Reported to Mfgr2020-03-06
Date Mfgr Received2020-02-13
Date Added to Maude2019-12-11
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOBSOLETE S9 AUTOSET - RMD HC
Product CodeBZD
Date Received2019-12-11
Model Number36125
Catalog Number36125
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age86 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESMED LTD
Manufacturer Address1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-11

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