BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIMADZU

    MDR report key: 10528 · Received October 12, 1993

    Report

    Report Number
    MW4000013
    Event Type
    Injury
    Date Received
    October 12, 1993
    Date of Event
    June 15, 1993
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT. RPTR IS CALLING BECAUSE HE FEELS THAT NOTHING HAS BEEN DONE DESPITE HIS EFFORTS IN CALLING THE STATE AND LOCAL HEALTH DEPT, AND RADIATION SAFETY. HE REPORTS THAT HE IS NOW AWARE THAT THE SAME FACILITY "HAS INJURED THREE OTHER PEOPLE" SINCE HIS EXPERIENCE IN THIS MACHINE IN 1993. IN ONE INSTANCE THE TABLE TOP TILTED, DUMPING A LADY ONTO THE FLOOR AND BREAKING HER HIP. ANOTHER MALE PT EXPERIENCED A RADIATION OVEREXPOSURE, AND YET A THIRD PT SUSTAINED AN UNSPECIFIED INJURY. RPTR FEELS THAT EVERYONE INVOLVED FROM THE "GOVERNMENT ON DOWN" TO THE END USER SHOULD BE "FIRED" FOR ALLOWING THIS DEVICE TO REMAIN IN USE. RPTR ALSO STATED HE BELIEVES THE HOSPITAL SHOULD BE CLOSED DUE TO THIS MACHINE.

    Description of Event or Problem · 2

    THIS IS A FOLLOW UP REPORT. RPTR IS CALLING BECAUSE HE FEELS THAT NOTHING HAS BEEN DONE DESPITE HIS EFFORTS IN CALLING THE STATE AND LOCAL HEALTH DEPT, AND RADIATION SAFETY. HE REPORTS THAT HE IS NOW AWARE THAT THE SAME FACILITY "HAS INJURED THREE OTHER PEOPLE" SINCE HIS EXPERIENCE IN THIS MACHINE IN 1993. IN ONE INSTANCE THE TABLE TOP TILTED, DUMPING A LADY ONTO THE FLOOR AND BREAKING HER HIP. ANOTHER MALE PT EXPERIENCED A RADIATION OVEREXPOSURE, AND YET A THIRD PT SUSTAINED AN UNSPECIFIED INJURY. RPTR FEELS THAT EVERYONE INVOLVED "FROM THE GOVERNMENT ON DOWN" TO THE END USER SHOULD BE "FIRED" FOR ALLOWING THIS DEVICE TO REMAIN IN USE. RPTR ALSO STATED HE BELIEVES THE HOSPITAL SHOULD BE CLOSED DUE TO THIS MACHINE. THE EVENT DATES FOR THE OTHER THREE PTS INVOLVED ARE UNSPECIFIED.

    Description of Event or Problem · 3

    THIS IS A FOLLOW UP REPORT. RPTR IS CALLING BECAUSE HE FEELS THAT NOTHING IS BEING DONE DESPITE HIS EFFORTS IN CALLING THE STATE AND LOCAL HEALTH DEPT, AND RADIATION SAFETY. HE REPORTS THAT HE IS NOW AWARE THAT THE SAME FACILITY "HAS INJURED THREE OTHER PEOPLE" SINCE HIS EXPERIENCE IN THIS MACHINE IN 1993. IN ONE INSTANCE THE TABLE TOP TILTED, DUMPING A LADY ONTO THE FLOOR AND BREAKING HER HIP. ANOTHER MALE PT EXPERIENCED A RADIATION OVEREXPOSURE, AND YET A THIRD PT SUSTAINED AN UNSPECIFIED INJURY. RPTR FEELS THAT EVERYONE INVOLVED "FROM THE GOVERNMENT ON DOWN" TO THE END USER SHOULD BE "FIRED" FOR ALLOWING THIS DEVICE TO REMAIN IN USE. RPTR ALSO STATED HE BELIEVES THE HOSPITAL SHOULD BE CLOSED DUE TO THIS MACHINE. THE EVENT DATES FOR THE OTHER THREE PTS INVLOVED ARE UNSPECIFIED.

    Description of Event or Problem · 4

    THIS IS A FOLLOW UP REPORT. RPTR IS CALLING BECAUSE HE FEELS THAT NOTHING HAS BEEN DONE DESPITE HIS EFFORTS IN CALLING THE STATE AND LOCAL HEALTH DEPT, AND RADIATION SAFETY. HE REPORTS THAT HE IS NOW ARWARE THAT THE SMAE FACILITY "HAS INJURED THREE OTHER PEOPLE" SINCE HIS EXPERIENCE IN THIS MACHINE IN 1993. IN ONE INSTANCE THE TABLE TOP TILTED, DUMPING A LADY ONTO THE FLOOR AND BREAKING HER HIP. ANOTHER MALE PT EXPERIENCED A RADIATION OVEREXPOSURE, AND YET A THIRD PT SUSTAINED AN UNSPECIFIED INJURY. RPTR FEELS THAT EVERYONE INVLOVED "FROM THE GOVERNMENT ON DOWN" TO THE END USER SHOULD BE "FIRED" FOR ALLOWING THIS DEVICE TO REMAIN IN USE. RPTR ALSO STATED HE BELIEVES THE HOSPITAL SHOULD BE CLOSED DUE TO THIS MACHINE. THE EVENT DATES FOR THE OTHER THREE PTS INVOLVED ARE UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHIMADZU MRI SCANNER JAK SHIMADZU MEDICAL SYSTEMS 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO
    2 NO INFO
    3 NO INFO
    4 NO INFO