BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APLIO XG

    MDR report key: 7013659 · Received November 9, 2017

    Report

    Report Number
    7013659
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    September 20, 2017
    Report Date
    September 29, 2017
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ULTRASOUND MACHINE WENT DOWN; MEMORY BOARD DOWN. BIOMED ASSESSED THE ISSUE AND ORDERED PARTS. PART WAS SUPPOSED TO ARRIVE ONE AFTERNOON SO DEVICE WAS NOT AVAILABLE UNTIL THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792671 APLIO XG TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX TOSHIBA MEDICAL SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1