RESMED AIRSENSE 10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for RESMED AIRSENSE 10 manufactured by Resmed.

Event Text Entries

[94196531] Auto adjust cpap misreported device function and patient use. Patient was on auto adjust cpap device, device reported no pressure, flow, breathing rate, tidal volume or respirations. Not able to determine if medical device was working and/or if data was missing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073761
MDR Report Key7086790
Date Received2017-12-04
Date of Report2017-12-01
Date of Event2017-11-25
Date Added to Maude2017-12-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRESMED AIRSENSE 10
Generic NameRESMED AIRSENSE 10
Product CodeMNR
Date Received2017-12-04
Model NumberAIRSENSE 10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerRESMED
Manufacturer AddressAU


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-12-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.