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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 DEU; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED LTD ASTRAL 100 DEU; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27052
Device Problems Unexpected Therapeutic Results (1631); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2022
Event Type  malfunction  
Event Description
It was reported to resmed that an astral device unexpectedly stopped ventilation, displayed a safety reset complete alarm and resumed ventilation after two minutes.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The astral device was returned to resmed.The investigation methods, results, and conclusions 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.
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.Performance testing could not reproduce the reported complaint, however, review of the device data logs confirmed an error message (system fault) and device restart within specification.Visual inspection of the main circuit board revealed contamination from capacitor leakage.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a contaminated main circuit board.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that an astral device unexpectedly stopped ventilation, displayed a safety reset complete alarm and resumed ventilation after two minutes.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ASTRAL 100 DEU
Type of Device
VENTILATOR, CONTINUOUS (FACILITY/HOME)
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key15889333
MDR Text Key304591755
Report Number3007573469-2022-00791
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27052
Device Catalogue Number27052
Device Lot Number1117994
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2023
Distributor Facility Aware Date05/01/2023
Device Age89 MO
Date Report to Manufacturer05/26/2023
Date Manufacturer Received05/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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