BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - EUR4

    MDR report key: 6047883 · Received October 21, 2016

    Report

    Report Number
    3004604967-2016-01146
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE.RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED THEREFORE THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697490 ASTRAL 100 - EUR4 CBK RESMED LTD 27061

    Patients

    Seq Age Sex Outcome Treatment
    1