Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESMED LTD ASTRAL 150 - FUKUDA Back to Search Results
Model Number 27093
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The device was recalibrated to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that an astral device displayed an error message (sf115) related to atmospheric pressure measurement.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported sf115 was due to an isolated component failure within the device main circuit board.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 displayed an error message (sf115) related to atmospheric pressure measurement.There was no patient harm or serious injury reported as a result of this incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASTRAL 150 - FUKUDA
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key11631265
MDR Text Key246276865
Report Number3004604967-2021-00484
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00619498270934
UDI-Public(01)00619498270934(10)1368947
Combination Product (y/n)N
PMA/PMN Number
K152068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27093
Device Catalogue Number27093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Distributor Facility Aware Date06/07/2021
Date Manufacturer Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-