BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-IV MAMMOGRAPHY SYSTEM

    MDR report key: 184380 · Received August 17, 1998

    Report

    Report Number
    1220984-1998-00027
    Event Type
    Malfunction
    Date Received
    August 17, 1998
    Date of Event
    July 1, 1998
    Report Date
    August 14, 1998
    Manufacturer
    LORAD DIVISION OF TREX MEDICAL
    Product Code
    IZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WHEEL CHAIRED PATIENT ACCIDENTALLY PRESSED THE C-ARM DOWN BUTTON WHILE PULLING HERSELF FORWARD USING THE PATIENT HANDLE BARS. THE BUCKY ALLEGEDLY WAS CAUGHT BY THE CHAIR AND THE BUCKY COVER WAS PULLED OFF. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-IV MAMMOGRAPHY SYSTEM RADIOLOGIC IZH LORAD DIVISION OF TREX MEDICAL M-IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN