BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORAD MIV MAMMOGRAPHY SYSTEM

    MDR report key: 1481398 · Received September 22, 2009

    Report

    Report Number
    1220984-2009-00001
    Event Type
    Injury
    Date Received
    September 22, 2009
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 25, 2009, HOLOGIC WAS CONTACTED BY AN INSURANCE REPRESENTATIVE REGARDING A WORKMEN'S COMPENSATION CLAIM FILED BY THEIR CLIENT. IT WAS REPORTED THAT THE USE OF THE HOLOGIC MIV MAMMOGRAPHY SYSTEM CAUSED A REPETITIVE MOTION INJURY. IT WAS LEARNED THAT A FIRMWARE UPGRADE TO THE MIV MAMMOGRAPHY SYSTEM DID NOT CONTAIN AN INTERFACE WITH THE POWERAID USED BY FACILITY. THE INTERFACE ALLOWS THE MIV MAMMOGRAPHY SYSTEM TO WORK WITH CUSTOMER'S POWERAID IN A MOBILE ENVIRONMENT. THE POWERAID IS AN ELECTRICAL LINE CONDITIONING UNIT USED IN SOME MOBILE CUSTOMER SITES. IT IS REPORTED THAT WITHOUT THE INTERFACE, THE TECHNOLOGIST HAD TO CHANGE HER NORMAL WORK FLOW WHEN USING THE SYSTEM, CAUSING THE ALLEGED INJURY. THERE WERE NO REPORTS OF SIMILAR PROBLEMS WITH ANY OTHER CUSTOMERS USING THE SAME FIRMWARE.

    Description of Event or Problem · 1

    A MAMMOGRAPHY TECHNOLOGIST AT THE HOSPITAL IS REPORTED TO HAVE A REPETITIVE MOTION INJURY, AS A RESULT OF USING A LORAD MIV MAMMOGRAPHY SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1