BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    MDR report key: 3159313 · Received June 4, 2013

    Report

    Report Number
    1220984-2013-00002
    Event Type
    Other
    Date Received
    June 4, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 4, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE HOLOGIC FIELD ENGINEER ARRIVED ON SITE HE FOUND THE FOOT-SWITCHES HAD ALREADY BEEN DISCONNECTED FROM THE SYSTEM BY THE SITE BIOMEDICAL PERSONNEL. THE HOLOGIC FIELD ENGINEER REPORTED NO PROBLEM WAS FOUND WITH THE SYSTEM OTHER THAN THE EMERGENCY STOP-SWITCHES HAD BEEN BLOCKED ON THE SYSTEM WITH ROLES OF TAPE. THIS WOULD PREVENT EASY ACCESS TO THESE SWITCHES IN AN EMERGENCY SITUATION. BOTH FOOT-SWITCHES WERE REPLACED AND THE SYSTEM IS FUNCTIONING PROPERLY. THE FOOT-SWITCHES WERE RETURNED TO THE FACTORY FOR EVALUATION BY AN HOLOGIC ENGINEER. IT WAS REPORTED THAT NO HARDWARE ISSUES WERE APPARENT AND NO ISSUES WERE FOUND WITH THE CONTINUITY OF THE C-ARM UP AND DOWN CIRCUITS. THE CONNECTORS SHOWED NO SIGN OF DAMAGE. HOLOGIC WAS UNABLE TO DETERMINE WHAT CAUSED THIS PARTICULAR EVENT. HOLOGIC DOES INSTRUCT USERS IN THE USER MANUAL AND DURING APPLICATIONS TRAINING TO USE CAUTION WHEN A PATIENT IS IN A WHEELCHAIR. THIS IS TO ENSURE THE WHEELS OF THE CHAIR DO NOT COME IN CONTACT WITH THE FOOT-SWITCHES AND CAUSE INADVERTENT C-ARM MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MAMMOGRAPHY PROCEDURE WAS BEING PERFORMED ON A PATIENT IN A WHEELCHAIR. THE TECHNOLOGIST REPORTED THE C-ARM DID NOT STOP WHEN COMING DOWN AND LANDED ON A PATIENT'S LEG. THE TECHNOLOGIST DID NOT USE THE EMERGENCY STOP BUTTON AS SHE SAID THE C-ARM FELL TOO FAST. THE PATIENT WAS SEEN IN THE HOSPITAL EMERGENCY ROOM. IT WAS REPORTED THAT THE PATIENT'S LEG WAS BRUISED, BUT SHE IS REPORTED TO BE DOING FINE. THE USER ALSO STATED THEY HAD REPORTED TO HOLOGIC A PROBLEM WITH THIS SYSTEM A FEW WEEKS PRIOR TO THIS INCIDENT. IT WAS REPORTED THAT VERTICAL TRAVEL WAS INITIATED USING THE FOOT-SWITCH, BUT MOVEMENT CONTINUED AFTER THE FOOT-SWITCH WAS RELEASED. A HOLOGIC ENGINEER CHECKED THE SYSTEM AT THAT TIME AND HAD REMOVED DUST AND DIRT FROM THE FOOT-SWITCHES, BUT FOUND THEM TO BE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247268 SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other