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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA; Continuous, ventilator, home use
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RESMED LTD ASTRAL 150 DBL KIT FRA; Continuous, ventilator, home use Back to Search Results
Model Number 27074
Device Problems Failure to Calibrate (2440); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 08/06/2021
Event Type  Death  
Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that a trached patient was found on the floor of the nursing home with the astral 150 tubing disconnected from the device.Resuscitation efforts were unsuccessful and the patient subsequently expired.Device is currently in police possession.There was no reported allegation of device malfunction or allegation that the device caused or contributed to the reported event.
 
Event Description
It was reported to resmed that a trached patient was found on the floor of the nursing home with the astral 150 tubing disconnected from the device.Resuscitation efforts were unsuccessful and the patient subsequently expired.Device is currently in police possession.There was no reported allegation of device malfunction or allegation that the device caused or contributed to the reported event.During evaluation of the device by resmed, the device failed to complete its internal self-test and battery was degraded.
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.Review of the device data logs revealed on the date of the reported event, ventilation was disrupted and disconnection alarm was activated, as expected, to alert the carer/user.All alarms performed to specification.Based on all available evidence, the investigation determined that the reported complaint was due circuit disconnection.The investigation also identified contamination of the pneumatic block and indications of a degrading battery.The failure modes are not related to the reported event, and did not affect the ability of the device to deliver therapy.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the failure to complete its internal self-test was due to contamination and degraded battery was due to an isolated component failure within the device battery assembly.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 150 DBL KIT FRA
Type of Device
Continuous, ventilator, home use
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key12677626
MDR Text Key277837812
Report Number3007573469-2021-01087
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
Reporter Country CodeFR
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 10/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number27074
Device Catalogue Number27074
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/27/2022
Distributor Facility Aware Date09/29/2022
Device Age66 MO
Event Location Nursing Home
Date Report to Manufacturer10/27/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2021
Supplement Dates Manufacturer Received09/29/2022
Supplement Dates FDA Received10/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age30 YR
Patient SexFemale
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