BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILEDART

    MDR report key: 1449491 · Received August 14, 2009

    Report

    Report Number
    1449491
    Event Type
    Malfunction
    Date Received
    August 14, 2009
    Date of Event
    June 28, 2009
    Report Date
    August 12, 2009
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN A CODE - RADIOLOGY HAD RESPONDED TO BEDSIDE - A CHEST X-RAY WAS REQUESTED. THE DR X-RAY DETECTOR WAS UNDER THE PATIENT, AND A CHEST IMAGE WAS ACQUIRED. BEFORE THE TECH COULD REMOVE THE DR PLATE FROM UNDER THE CHILD, THE PHYSICIAN CALLED FOR DEFIBRILLATION. TECH SAID THEY NEEDED TO REMOVE THE PLATE FIRST BUT DEFIBRILLATION OCCURRED ANYWAY. THE X-RAY UNIT IS NOT WORKING PROPERLY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILEDART X-RAY UNIT, MOBILE, DIGITAL IZL SHIMADZU MEDICAL SYSTEMS DART *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO OTHER| OTHER