BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS CATH LAB SYSTEM

    MDR report key: 33000 · Received May 14, 1996

    Report

    Report Number
    MW1009098
    Event Type
    Malfunction
    Date Received
    May 14, 1996
    Date of Event
    May 11, 1996
    Report Date
    May 13, 1996
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    IZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SVC TECH WAS REPAIRING THE CATH LAB SYSTEM. IT WAS REPORTED TO SVC THAT FLUORO WAS "STAYING ON." WHILE TECH WAS CHECKING THE FLUORO FOOT SWITCH (SYSTEM NOT ON AT THIS TIME), A NURSE CAME INTO THE ROOM AND PLACED A CINE FILM CANISTER NOT THE CINE CAMERA. THIS CAUSED THE SYSTEM TO IMMEDIATELY PRODUCE CINE X-RAY. BOTH THE TECH AND NURSE WERE TEMPORARILY EXPOSED AS NEITHER WERE WEARING LEAD. THE TECH PUT ON LEAD AND WENT BACK INTO THE ROOM TO FIND THAT THE CINE FOOT SWITCH WAS THE CAUSE OF THE PROBLEM, NOT FLUORO. FAILURE MODE IS SUCH THAT THE PLASTIC ACTUATORS IN FOOT SWITCH BROKE OFF AND CAUSED THE ACTIVATION. THIS HAS OCCURRED ON MORE THAN ONE OCCASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS CATH LAB SYSTEM CATH LAB SYSTEM IZJ SIEMENS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO