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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED LTD ASTRAL 150 DBL KIT FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27074
Device Problems Battery Problem (2885); Protective Measures Problem (3015); Unexpected Shutdown (4019)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/13/2022
Event Type  Injury  
Manufacturer Narrative
The device external battery was returned to resmed for an extensive engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.Resmed reference#: (b)(4).Device received, evaluation pending.
 
Event Description
It was reported to resmed that an astral device powered down unexpectedly.It was reported the patient's oxygen saturation dropped to 78% due to the reported issue.The patient was manually ventilated and placed on a different device.
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.Review of the device data logs confirmed total power failure without prior warning and revealed error messages (sf180) related to a battery charger fault.Based on all available information and investigation findings, the investigation determined that sf180 and total power failure without prior warning were due to an isolated component failure within the device battery assembly.The astral 100/150 provides the following warning: - ¿the internal battery is not intended to serve as a primary power source.It should only be used when other sources are not available or briefly when necessary; for example, when changing power sources¿.The astral 100/150 user guide also provides the following warning: ¿ ¿for ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device.Failure to do so may result in patient injury or death.Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers.These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction." 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 powered down unexpectedly.It was reported the patient's oxygen saturation dropped to 78% due to the reported issue.The patient was manually ventilated and placed on a different device.
 
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Brand Name
ASTRAL 150 DBL 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 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 Key14992062
MDR Text Key295765880
Report Number3004604967-2022-00466
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 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number27074
Device Catalogue Number27074
Device Lot Number1164746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2022
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/21/2023
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient SexMale
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