AIRSENSE 10 AUTOSET USA TRI 37208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-05 for AIRSENSE 10 AUTOSET USA TRI 37208 manufactured by Resmed Ltd.

Event Text Entries

[182119828] 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. Resmed reference#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[182119829] It was reported to resmed that an airsense 10 device caught fire. There was no patient harm or a serious injury reported as result of this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004604967-2020-00219
MDR Report Key9673958
Report SourceOTHER
Date Received2020-02-05
Date of Report2020-02-05
Date Facility Aware2020-01-09
Date Mfgr Received2020-01-09
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. MICHELLE HUGHES
Manufacturer Street1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA
Manufacturer CitySYDNEY, NSW 2153
Manufacturer CountryAU
Manufacturer Postal2153
Manufacturer G1RESMED LTD
Manufacturer Street1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA
Manufacturer CitySYDNEY, NSW 2153
Manufacturer CountryAU
Manufacturer Postal Code2153
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRSENSE 10 AUTOSET USA TRI
Product CodeBZD
Date Received2020-02-05
Model Number37208
Catalog Number37208
Lot Number1247647
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRESMED LTD
Manufacturer Address1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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