BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA 3.0T

    MDR report key: 3962611 · Received July 15, 2014

    Report

    Report Number
    3003768277-2014-00078
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K110151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A RADIOLOGIST WAS OPERATING THE TROLLEY TOGETHER WITH A NURSE, WHILE A PATIENT WAS POSITIONED ON TOP OF THE TROLLEY. AT THE ENTRANCE OF THE EXAMINATION ROOM, THE FLOOR IS SLOPED. AT THIS POINT THE RADIOLOGIST GOT HIS FOOT STUCK BETWEEN THE FLOOR AND THE HYDRAULIC COLUMN OF THE TROLLEY. THE RADIOLOGIST WAS WEARING SLIPPERS WITH OPEN TOES. KINETIC ENERGY OF THE TROLLEY CAUSED THE ENGINEER TO BREAK HIS TOE. THE RISK MAINLY EXISTS WHEN THE TROLLEY IS OPERATED BY 2 PERSONS. THEREFORE SPECIAL CARE MUST BE TAKEN WHEN USING THE TROLLEY TO FOLLOW THE INSTRUCTIONS FOR USE OF THE TROLLEY WITHIN HOSPITAL OR IMAGING FACILITY INCLUDING TYPE OF REQUIRED FOOT WEAR. PHILIPS IS WORKING ON ACTION THAT CONSISTS OF THE REPLACEMENT OF THE FRONT AND REAR COVERS OF THE INGENIA MR FLEX TRAK TROLLEY WITH NEW COVERS WITH A PROTECTION BUMPER THAT PREVENTS FOOT CLAMPING.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A RADIOLOGIST SUSTAINED A BROKEN TOE AND LOST HIS NAIL WHILE OPERATING THE TROLLEY TOGETHER WITH A NURSE, WHILE A PATIENT WAS POSITIONED ON TOP OF THE TROLLEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412787 INGENIA 3.0T LNH PHILIPS HEALTHCARE 781377

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other