BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIMADZU RADSPEED

    MDR report key: 10074715 · Received May 19, 2020

    Report

    Report Number
    MW5094571
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    February 26, 2020
    Report Date
    May 15, 2020
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE SHIMADZU RADSPEED WILL CHANGE ITS MAS AND TIME BY ITSELF. THE FIRST MACHINE OCCURRENCE WAS DATED (B)(6) 2020. WE HAVE HAD A RADSPEED DO THE SAME THING ON (B)(6) 2020. SYSTEM ID FOR THE FIRST MACHINE IS (B)(4) AND THE 2ND MACHINE IS (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536797 SHIMADZU RADSPEED SYSTEM, X-RAY, STATIONARY KPR SHIMADZU MEDICAL SYSTEMS RADSPEED
    536798 SHIMADZU RADSPEED SYSTEM, X-RAY, STATIONARY KPR SHIMADZU MEDICAL SYSTEMS RADSPEED

    Patients

    Seq Age Sex Outcome Treatment
    1