BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1055MM CAMERA

    MDR report key: 278056 · Received May 2, 2000

    Report

    Report Number
    1217116-2000-00008
    Event Type
    Malfunction
    Date Received
    May 2, 2000
    Date of Event
    April 14, 2000
    Report Date
    April 14, 2000
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IXJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT WAS LYING ON THE TABLE AND THE TECHNOLOGIST LIFTED THE IMAGE INTENSFIER (II) ASSEMBLY WITH ONE HAND ON THE II AND ONE HAND ON THE UNDERSIDE OF THE 105MM CINE CAMERA. AS THE TECHNOLOGIST WAS RAISING THE II ASSEMBLY, THE 105MM CAMERA DETACHED AND BEGAN TO FALL TOWARDS THE PT. THE TECHNOLOGIST WAS ABLE TO PARTIALLY DEFLECT THE CAMERA BUT THE PT WAS STRUCK A GLANCING BLOW ON THE FOREHEAD. THE PT INITIALLY COMPLAINED OF A HEADACHE AND A C-COLLAR WAS PLACED ON HIS NECK. SUBSEQUENT X-RAYS OF THE PT WERE NEGATIVE AND REPORTED INFO AT THIS TIME INDICATES THAT THE PT WAS NOT SERIOUSLY INJURIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1055MM CAMERA CINE CAMERA IXJ PHILIPS MEDICAL SYSTEMS 9807-500-40001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN