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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 SGL KIT - FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED LTD ASTRAL 100 SGL KIT - FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27072
Device Problems Leak/Splash (1354); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2023
Event Type  malfunction  
Event Description
It was reported to resmed that an astral device displayed an error message (sf200) related to blower temperature and had took on water.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).Device received; investigation pending.
 
Event Description
It was reported to resmed that an astral device displayed an error message (sf200) related to blower temperature and had took on water.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint.The pneumatic block was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to water 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 100 SGL KIT - FRA
Type of Device
VENTILATOR, CONTINUOUS (FACILITY/HOME)
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
Manufacturer (Section G)
RESMED PTY LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS   2153
Manufacturer Contact
michelle hughes
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS   2153
MDR Report Key16359549
MDR Text Key309401122
Report Number3004604967-2023-00099
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K172875
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27072
Device Catalogue Number27072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2023
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/05/2024
Initial Date Manufacturer Received 01/13/2023
Initial Date FDA Received02/11/2023
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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