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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 100 - EUR1; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED PTY LTD ASTRAL 100 - EUR1; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27011
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported to resmed that an astral device displayed an error message (sf190) related to outlet pressure sensor and an error message (sf133) related to peep valve pressure measurement.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The device was returned to a third party service center and an evaluation confirmed the complaint.The pneumatic block sensor board was replaced to address the issues.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 100 - EUR1
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 Key19218464
MDR Text Key341458046
Report Number3007573469-2024-00108
Device Sequence Number1
Product Code NOU
UDI-Device Identifier00619498270118
UDI-Public(01)00619498270118(11)221110(10)1668496
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation 505
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27011
Device Catalogue Number27011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2024
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2024
Distributor Facility Aware Date04/02/2024
Device Age16 MO
Date Report to Manufacturer04/30/2024
Date Manufacturer Received04/02/2024
Date Device Manufactured11/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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