BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 10987627 · Received December 10, 2020

    Report

    Report Number
    3004604967-2020-01182
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 10, 2020
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270033
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. RESMED REFERENCE#: PR 2153193.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST AND DISPLAYED ERROR MESSAGES (SF101 AND SF131) RELATED TO PRESSURE MEASUREMENT AND MAIN BLOWER TEMPERATURE SENSOR RESPECTIVELY. 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
    1454170 ASTRAL 150 - AMER CBK RESMED LTD 27003 1361913 00619498270033

    Patients

    Seq Age Sex Outcome Treatment
    1