BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL DC ADAPTER

    MDR report key: 7031165 · Received November 14, 2017

    Report

    Report Number
    3004604967-2017-01619
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 REPORTED POWER ISSUE WAS DUE TO A DEFECTIVE CABLE OF THE DC ADAPTER. THE POWER CABLE 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 DC ADAPTER FAILED TO PROVIDE POWER TO THE UNIT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806472 ASTRAL DC ADAPTER CBK RESMED LTD 27925

    Patients

    Seq Age Sex Outcome Treatment
    1