BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8 HORIZONTAL

    MDR report key: 4093001 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00177
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING A CHARGE. WHEN THE AC POWER CORD IS PLUGGED INTO THE AC INPUT MODULE, THE UNIT WILL APPEAR TO CHARGE AND ILLUMINATE THE AC POWER LED. AFTER SOME NUMBER OF MINUTES, IF THE UNIT IS BUMPED, THE AC POWER LED WILL GO OUT AND THE UNIT WILL STOP CHARGING. THE UNIT WILL ENGAGE IN MONITORING AS LONG AS THEY AC INPUT MODULE IS MAKING CONTACT WITH THE SOLDER POINTS. THERE WAS NO PT INDECENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545749 RAD-8 HORIZONTAL DQA MASIMO CORPORATION 9190

    Patients

    Seq Age Sex Outcome Treatment
    1