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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER
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RESMED LTD ASTRAL 150 - AMER Back to Search Results
Model Number 27003
Device Problems Inadequate User Interface (2958); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to resmed and an evaluation confirmed the reported unresponsive touchscreen.The top case assembly was replaced to address the issue.The reported sf34 could not be reproduced.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that an astral device displayed an error message (sf34) related to power failure and had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
 
Event Description
It was reported to resmed that an astral device displayed an error message (sf34) related to power failure and had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported unresponsive touchscreen was due to physical damage.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
 
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Brand Name
ASTRAL 150 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key11660516
MDR Text Key247552071
Report Number3004604967-2021-00492
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K152068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27003
Device Catalogue Number27003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Distributor Facility Aware Date06/01/2021
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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