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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED PTY LTD ASTRAL 150 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27088
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
It was reported to resmed that an astral device did not power on.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The astral device was returned to a third party service center.Evaluation confirmed the reported complaint.The main circuit board was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
 
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Brand Name
ASTRAL 150 - APAC2
Type of Device
VENTILATOR, CONTINUOUS (FACILITY/HOME)
Manufacturer (Section D)
RESMED PTY LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key18416566
MDR Text Key331581733
Report Number3007573469-2023-00699
Device Sequence Number1
Product Code NOU
UDI-Device Identifier00619498270880
UDI-Public(01)00619498270880(11)180805(10)1322335
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 12/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2023
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 Manufacturer11/01/2023
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2023
Distributor Facility Aware Date11/30/2023
Device Age63 MO
Date Report to Manufacturer12/28/2023
Date Manufacturer Received11/30/2023
Date Device Manufactured08/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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