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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).
 
Event Description
It was reported to resmed that an astral battery triggered an error message (sf180) related to a battery charger fault.There was no patient harm or serious injury reported as a result of this incident.
 
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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 Key11558477
MDR Text Key243131597
Report Number3004604967-2021-00435
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K152068
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
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/24/2021
Initial Date Manufacturer Received 02/24/2021
Initial Date FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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