AIRSENSE 10 AUTOSET USA CO 37207

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-10 for AIRSENSE 10 AUTOSET USA CO 37207 manufactured by Resmed Ltd.

Event Text Entries

[185502744] The device was returned to resmed for an engineering investigation. Initial evaluation determined the device was performing to specifications. Visual inspection revealed thermal damage to the exterior of the device. The investigation methods, results, and conclusion are not finalized at this stage. When more information is available a supplemental report will be submitted. Resmed reference#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185502745] It was reported that an airsense 10 device caught fire. It was reported the patient? S son had a minor, small burn on neck due to debris; medical attention was not sought. The device was not in use at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004604967-2020-00349
MDR Report Key9814364
Report SourceDISTRIBUTOR
Date Received2020-03-10
Date of Report2020-03-10
Date Facility Aware2020-02-13
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
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 CO
Product CodeBZD
Date Received2020-03-10
Returned To Mfg2020-02-18
Model Number37207
Catalog Number37207
OperatorLAY USER/PATIENT
Device AvailabilityR
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 2020-03-10

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