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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC2
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RESMED LTD ASTRAL 150 - APAC2 Back to Search Results
Model Number 27088
Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2022
Event Type  malfunction  
Manufacturer Narrative
The astral device was returned to a resmed authorized third party service center.Evaluation confirmed the reported complaint.The battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.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 an astral device displayed an internal battery degraded warning alarm.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ASTRAL 150 - APAC2
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key16359507
MDR Text Key309371124
Report Number3007573469-2023-00097
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00619498270880
UDI-Public(01)00619498270880(10)1532763
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation 505
Type of Report Initial
Report Date 02/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27088
Device Catalogue Number27088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/09/2023
Distributor Facility Aware Date01/12/2023
Device Age20 MO
Date Report to Manufacturer02/09/2023
Date Manufacturer Received01/12/2023
Date Device Manufactured05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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