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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 Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported to resmed that an astral device had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
 
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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 Key11310561
MDR Text Key231318730
Report Number3007573469-2021-00278
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00619498270033
UDI-Public(01)00619498270033(11)190416(10)1374323
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2021
Distributor Facility Aware Date01/19/2021
Device Age20 MO
Date Report to Manufacturer02/10/2021
Date Manufacturer Received01/19/2021
Date Device Manufactured04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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