BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - APAC2

    MDR report key: 19553650 · Received June 17, 2024

    Report

    Report Number
    3007573469-2024-00167
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 17, 2024
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO SUPER CAPACITOR ELECTROLYTE LEAK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.RESMED REFERENCE #: PR 3083077

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO THE SUPER CAPACITOR. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251016 ASTRAL 100 - APAC2 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27082 1406654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown