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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 DEU
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RESMED LTD ASTRAL 100 DEU Back to Search Results
Model Number 27052
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Inadequate User Interface (2958); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to resmed and an evaluation confirmed the complaint.The top case , main circuit board and internal battery required replacement to address the issues.The device was deemed beyond repair and scrapped.Resmed reference#: pr (b)(4).
 
Event Description
It was reported to resmed that an astral device had a defective display, power source detection issue and an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.
 
Event Description
It was reported to resmed that an astral device had a defective display, power source detection issue and an internal battery with a reduced level of capacity.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.Signs of physical damage were observed on the device.Review of the device data logs revealed an internal battery degraded warning alarm.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported display issue was due to physical damage while the internal battery degraded warning alarm was due to the battery controller software and the power source issue was due to soldering process during manufacturing.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 DEU
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key11733968
MDR Text Key249954098
Report Number3007573469-2021-00546
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2021
Distributor Facility Aware Date07/12/2021
Device Age67 MO
Date Report to Manufacturer08/10/2021
Date Manufacturer Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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