BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSPEED GENERAL X-RAY SYSTEM

    MDR report key: 8731363 · Received June 24, 2019

    Report

    Report Number
    MW5087594
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    April 28, 2019
    Report Date
    June 7, 2019
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    TECH SAID SHE TOOK A RADIOLOGICAL IMAGE ON THE UPRIGHT WALL STAND AND RECEIVED NO IMAGE AFTER PRODUCING X-RAY. CORRECTIVE ACTION DID NOT RECOVER A PT IMAGE. PROBLEM OCCURRED WHILE USING A GENERAL X-RAY ROOM AND A DIGITAL IMAGE CAPTURE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523143 RADSPEED GENERAL X-RAY SYSTEM SYSTEM, X-RAY, STATIONARY KPR SHIMADZU MEDICAL SYSTEMS RADSPEED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR