BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D

    MDR report key: 2074622 · Received April 21, 2011

    Report

    Report Number
    1220984-2011-00002
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 20, 2011
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011 A HOLOGIC FIELD ENGINEER WENT TO THE SITE TO DETERMINE THE CAUSE OF THE INCIDENT. THE FIELD ENGINEER WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE FIELD ENGINEER DID NOTICE THE RIGHT SIDE LOCK WAS STICKING, BUT WAS LOCKING. HE ALSO NOTICED SOME A CHIPS IN THE PAINT ON THE X1.5 MAGNIFICATION POSITION AND FEELS THAT SOME OF THE TECHNOLOGISTS MAY BE USING THIS POSITION UNINTENTIONALLY. THE MAGNIFICATION STAND WAS OPERATING TO HOLOGIC'S SPECIFICATIONS WHEN SECURELY ATTACHED TO THE SYSTEM. THE FIELD ENGINEER REPLACED THE MAGNIFICATION STAND WITH A NEW ONE. PROPER FUNCTIONING WAS CONFIRMED PRIOR TO LEAVING THE FACILITY. THE MAGNIFICATION STAND IN QUESTION WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE MAGNIFICATION STAND WAS REC'D AND EVALUATED BY A MFG ENGINEER. MINOR RUBBING WAS NOTED ON THE LINKAGE TO THE LOCKING MECHANISM. THE MFG ENGINEER ATTEMPTED SEVERAL TIMES, BUT COULD NOT DUPLICATE THE REPORTED PROBLEM. IT WAS CONFIRMED THAT WHEN THE MAGNIFICATION STAND IS PROPERLY SECURED, IT REMAINS ATTACHED TO THE SYSTEM WHEN MOVED TO A 90 DEGREE ANGLE AS DESIGNED. THE CLINICAL SERVICE DEPT IS COORDINATING A CUSTOMER CARE VISIT TO THE SITE. DURING THE PROPOSED VISIT, A HOLOGIC APPLICATIONS SPECIALIST WILL REVIEW USE OF THE SELENIA DIMENSIONS SYSTEM INCLUDING HOW TO PROPERLY SECURE THE MAGNIFICATION STAND TO THE SYSTEM.

    Description of Event or Problem · 1

    THE MAGNIFICATION STAND FELL OFF THE SELENIA DIMENSIONS SYSTEM WHEN THE TECHNOLOGIST ROTATED THE C-ARM TO A 90 DEGREE ANGLE. WHEN THE MAGNIFICATION STAND FELL, IT LANDED ON THE PT'S FOOT. THE PT SAID SHE WAS "OKAY" AND DECLINED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other