BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DIMENSIONS

    MDR report key: 19172379 · Received April 24, 2024

    Report

    Report Number
    1220984-2024-00034
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 8, 2024
    Report Date
    September 5, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    UDI-DI
    15420045510524
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 510K FOR THE PRODUCT IS P080003.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED: IT WAS REPORTED THAT THE C-ARM ROTATED UPSIDE-DOWN WITHOUT OPERATOR INTERVENTION. THE 3DIMENSIONS SYSTEM ALSO FLAGGED WITH A SYSTEM ERROR (LEFT-SIDE SWITCH FAULT). THE FIELD ENGINEER (FE) WAS DISPATCHED TO THE SITE AND REPLACED THE CONTROL INSERTS, RESOLVING THE ISSUE. NO PATIENT OR USER INJURIES WERE REPORTED. A REVIEW OF THE DEVICE HISTORY SHOWED THIS ISSUE HAS NOT REOCCURRED SINCE THE PARTS WERE REPLACED. TWO CONTROL INSERTS WERE RETURNED. THE RETURNED CONTROL INSERTS WERE 1970 DAYS OLD AT REPLACEMENT. A VISUAL INSPECTION OF THE CONTROL INSERTS SHOWED THE CONTROL ROCKER WAS LOOSE AND DIFFICULT TO PRESS ON THE LEFT CONTROL INSERT. THE RIGHT CONTROL INSERT SHOWED SIGNS OF WEAR ON THE BUTTON BUT HAD NO DIFFICULTIES WHEN PRESSED. THE RETURNED CONTROL INSERTS WERE INSTALLED ON A WORKING GANTRY. WHEN TRYING TO MOVE THE C-ARM WITH THE LEFT CONTROL INSERT, THE MOVEMENT WAS INTERMITTENT. THE C-ARM WOULD NOT ALWAYS MOVE WHEN THE SLIDE/ROCKER BUTTON WAS PRESSED OR MOVED AT A DELAYED RATE. ADDITIONALLY, THE C ARM WOULD SOMETIMES ROTATE INSTEAD OF SLIDE WHEN THE BUTTON WAS PUSHED DOWN. THE RIGHT CONTROL INSERT WAS ABLE TO MOVE THE C-ARM BUT OCCASIONALLY HAD SOME DELAYS WHEN SLIDING UP AND DOWN. THE LEFT CONTROL INSERT WAS DISASSEMBLED. THE DOWEL PIN WAS STICKING OUT OF THE CONTROL ROCKER. ADDITIONALLY, THE TABS ON THE CONTROL ROCKER SHOWED SIGNIFICANT SIGNS OF WEAR. INVESTIGATION OF THE RETURNED CONTROL INSERTS CONFIRMED THE CAUSE OF THE UNCOMMANDED MOTION WAS DUE TO WEAR AND A BROKEN SLIDE/ROCK MOUNT. A CAPA WAS OPENED TO ADDRESS UNINTENDED MOTION CAUSED BY DIMENSIONS CONTROL INSERTS. THE CAPA IDENTIFIED THE SLIDE/ROCK MOUNT (PLASTIC SWITCH PIVOT MOUNT) WAS BREAKING CAUSING THE UNINTENDED MOTION. TO RESOLVE THE ISSUE, THE CAPA INCLUDED A REDESIGN OF THE PIVOT MOUNT/CONTROL SLIDE AND A MATERIAL CHANGE. CONCLUSION: A CAPA WAS OPENED FOR THIS ISSUE AND DESIGN UPDATES WERE IMPLEMENTED. FUTURE EVENTS WILL BE MONITORED AND TRENDED. COMPLAINT CONFIRMED: YES DEVICE HISTORY RECORD (DHR) REVIEW: THE COMPLAINT REVIEW IDENTIFIED THAT THE FAILING CONTROL INSERTS WERE ORIGINAL TO THE SYSTEM THEREFORE, THE DHR WAS REVIEWED. THERE WAS NO DISCREPANCY RELATED TO THE CONTROL INSERTS. SYSTEM PRODUCT CODE: 3DM-SYS-STD SERIAL NUMBER: (B)(6) SYSTEM MANUFACTURE DATE: 11/13/2018 SYSTEM INSTALLATION DATE: (B)(6) 2018 UNIQUE DEVICE IDENTIFIED (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON APRIL 8 THE C-ARM ROTATED UPSIDE-DOWN ON ITS OWN. THE FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND A STUCK SWITCH ERROR AND THE C-ARM HAD HIT. THE FIELD ENGINEER REPLACED SIDE SWITCHES AND PERFORMED TEST SHOTS. VERIFIED THAT THE SYSTEM WAS FUNCTIONING AS PER MANUFACTURER SPECIFICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948405 3DIMENSIONS MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC 3DM-SYS-STD 15420045510524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown