BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DIMENSIONS

    MDR report key: 12814009 · Received November 15, 2021

    Report

    Report Number
    1220984-2021-00051
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 15, 2021
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AUTOMATIC ROTATION DID NOT STOP AT MLO ORIENTATION AND INSTEAD WENT TO 90 DEGREES. THE C-ARM WAS ABLE TO BE MOVED MANUALLY TO CORRECT THE ANGLE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE REAR ROTARY SWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710210 3DIMENSIONS MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC 3DM-SYS-STD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown