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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK
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RESMED LTD ASTRAL BATTERY PACK Back to Search Results
Model Number 19620
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Event Description
It was reported to resmed that an astral device displayed a battery error message.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The astral device was returned to a resmed authorized third party service centre.Evaluation confirmed the reported complaint.The internal battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
 
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Brand Name
ASTRAL BATTERY PACK
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 Key14477739
MDR Text Key298051043
Report Number3004604967-2022-00364
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172875
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation 505
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number19620
Device Catalogue Number19620
Was Device Available for Evaluation? No
Distributor Facility Aware Date04/25/2022
Date Manufacturer Received04/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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