BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 6124551 · Received November 23, 2016

    Report

    Report Number
    6124551
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN TO CATH LAB FOR GASTRODUODENAL ARTERY (GDA) EMBOLIZATION. THE PATIENT WAS PREPPED AND INTUBATED. AS THE MD WAS ABOUT TO BEGIN THE PROCEDURE, THE FLUORO EQUIPMENT BEGAN ALARMING. MESSAGE DISPLAYED: "HOT TUBE". THE PATIENT WAS TRANSPORTED TO ANOTHER CATH LAB ROOM FOR THE PROCEDURE. IT WAS DETERMINED THE COOLING MECHANISM FOR THE C-ARM RAN OUT OF WATER TO COOL THE TUBE CAUSING IT TO OVERHEAT. IT WAS REPAIRED AND REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774760 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA SIEMENS MEDICAL SOLUTIONS USA, INC 10281299

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR OTHER, UNKNOWN| YES BUT THEY ARE NOT KNOWN