BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRITECHNO CINE CAMERA

    MDR report key: 160806 · Received March 30, 1998

    Report

    Report Number
    1217116-1998-00009
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    March 6, 1998
    Report Date
    March 6, 1998
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A CARDIAC CATHETERIZATION, THE TECHNOLOGIST WAS MOVING A LEAD SHIELD AND HE ACCIDENTLY STRUCK THE FILM MAGAZINE CAUSING IT TO DETACH FROM THE CINE CAMERA AND FALL AND HIT THE PT ON THE ABDOMEN. NO INJURIES OR IMPACT TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRITECHNO CINE CAMERA 35MM CINE CAMERA IZJ PHILIPS MEDICAL SYSTEMS 9896-010-04831 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other