BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - APAC1

    MDR report key: 11572021 · Received March 25, 2021

    Report

    Report Number
    3004604967-2021-00443
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    January 27, 2021
    Report Date
    March 25, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270811
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE MAIN CIRCUT BOARD (PCB) WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE #: PR 2231392.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470210 ASTRAL 100 - APAC1 CBK RESMED LTD 27081 00619498270811

    Patients

    Seq Age Sex Outcome Treatment
    1