BEUDAMED
    FDA Adverse Event Other Summary report: N

    LORAD MIV MAMMAGRAPHY SYSTEMS

    MDR report key: 594279 · Received April 19, 2005

    Report

    Report Number
    1220984-2005-00001
    Event Type
    Other
    Date Received
    April 19, 2005
    Date of Event
    April 12, 2005
    Report Date
    April 19, 2005
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A TECHNOLOGIST WAS REPARING AN MIV MAMMOGRAPHY SYSTEM FOR A BIOPSY VIEW. THEY DEPRESSED THE FOOTSWITCH TO MOVE THE C-ARM TO A 180-DEGREE ANGLE. THE FOOTSWITCH WAS LOCATED DIRECTLY BELOW THE C-ARM. THEIR FOOT BECAME TRAPPED IN-BETWEEN THE C-ARM AND FOOTSWITCH. ANOTHER TECHNOLOGIST ACTIVATED THE MIV EMERGENCY STOP SWITCH. THE MIV SYSTEM SHUT DOWN. THE TECHNOLOGIST REQUIRED ASSISTANCE FROM THE OTHER TECHNOLOGIST IN REMOVING THEIR FOOT. NO PT WAS IN THE ROOM AT THE TIME OF THE INCIDENT. THE TECHNOLOGIST WAS SEEN IN THE EMERGENCY ROOM, WHERE X-RAYS SHOWED THAT NO BONES WERE BROKE. HOWEVER, THE TECHNOLOGIST DID HAVE CONTUSIONS ON THEIR FOOT. THEY WERE ADVISED TO PUT INCE ON THEIR FOOT, KEEP IT ELEVATED AND STAY OFF OF IT AS MUCH AS POSSIBLE. THE TECHNOLOGIST RETURNED TO WORK THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD MIV MAMMAGRAPHY SYSTEMS MAMMOGRAPHY SYSTEM IZH HOLOGIC, INC. MIV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other