BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL DC ADAPTER

    MDR report key: 6680976 · Received June 30, 2017

    Report

    Report Number
    3004604967-2017-00902
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Report Date
    December 21, 2017
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. PERFORMANCE TESTING FOUND THAT THE DEVICE WILL POWER OFF WHEN THE DC ADAPTER IS MOVED IN THE DC RECEPTACLE AND THE POWER WILL STAY ON IF THE CONNECTION IS UNDISTURBED. BASED ON ALL AVAILABLE INFORMATION THE ASTRAL DC ADAPTER WAS UNABLE TO RELIABLY PROVIDE POWER TO THE DEVICE. THE ASTRAL DC ADAPTER WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION. THE DEVICE HAS NOT YET RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE POWER SUPPLY UNIT FAILED TO CHARGE AN ASTRAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE POWER SUPPLY UNIT FAILED TO CHARGE AN ASTRAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460496 ASTRAL DC ADAPTER CBK RESMED LTD 27925

    Patients

    Seq Age Sex Outcome Treatment
    1