BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIAL MAMMOGRAPHY SYSTEM

    MDR report key: 2469311 · Received February 14, 2012

    Report

    Report Number
    1220984-2012-00001
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    January 16, 2012
    Report Date
    February 14, 2012
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SELENIA SYSTEM WAS EVALUATED BY AN HOLOGIC FIELD ENGINEER ON (B)(4) 2012 AND WAS FOUND TO BE WORKING PROPERLY. THE TECHNOLOGIST STATED THE PT WAS VERY NERVOUS AND MAY HAVE INADVERTENTLY DEPRESSED THE CONTROL SWITCH AT THE BACK OF THE SYSTEM C-ARM ALLOWING FOR THE CONTINUATION OF THE DOWNWARD MOVEMENT. THE OPERATOR'S MANUAL ADVISES CAUTION IN THE PLACEMENT OF THE PT'S HANDS DURING A PROCEDURE TO AVOID THIS TYPE OF INCIDENT. IN ADDITION, THE USE OF THE EMERGENCY OFF SWITCH WOULD HAVE IMMEDIATELY SHUTDOWN THE SYSTEM, PREVENTING THE CONTINUED DOWNWARD MOTION OF THE C-ARM. THE TECHNOLOGIST DID NOT USE THE EMERGENCY OFF SWITCH DURING THIS EVENT. THE SYSTEM WAS IMMEDIATELY RETURNED TO SERVICE AFTER THE EVAL BY THE HOLOGIC FIELD ENGINEER. NO OTHER OCCURRENCES HAVE BEEN REPORTED WITH THIS SYSTEM.

    Description of Event or Problem · 1

    THE PT WAS SEATED IN A CHAIR AND WAS BEING POSITIONED FOR A NEEDLE LOCALIZATION PROCEDURE. THE SELENIA C-ARM WAS LOWERED BY THE TECHNOLOGIST BY DEPRESSING THE FOOTSWITCH. WHEN THE FOOTSWITCH WAS RELEASED THE C-ARM CONTINUED THE DOWNWARD MOTION. THE TECHNOLOGIST DEPRESSED THE UP-COMMAND FOOTSWITCH, BUT THE C-ARM CONTINUED DOWNWARD ONTO THE PT'S LEFT LEG. THE SYSTEM WAS EVENTUALLY STOPPED VIA PHYSICAL RESISTANCE BY TWO OTHER INDIVIDUALS CALLED TO ASSIST THE TECHNOLOGIST DURING THIS EVENT. THE EMERGENCY OFF SWITCH WAS NOT USED. THE TECHNOLOGIST STATED PT'S LEG HAD A RED MARK WHERE IT CAME IN CONTACT WITH THE SELENIA C-ARM. THE PT WAS BROUGHT TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED THAT SAME DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other