BEUDAMED
    FDA Adverse Event Other Summary report: N

    BI-PLANE SPECIAL PROCEDURES FLUOROSCOPE

    MDR report key: 436131 · Received January 2, 2003

    Report

    Report Number
    MW1027142
    Event Type
    Other
    Date Received
    January 2, 2003
    Date of Event
    October 10, 2002
    Report Date
    January 2, 2003
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RADIATION SKIN BURN THAT RESULTED FROM A LONG COMPLICATED INTERVENTIONAL CARDIOVASCULAR ANGIOPLASTY PROCEDURE. THE TOTAL FLUOROSCOPY TIME WAS 95 MINUTES WITH 64 DIGITAL CINE RUNS. THE HIGH RADIATION DOSE WAS A RESULT OF THE LONG PROCEDURE AND THE VERY "LARGE" PT SIZE. THIS RESULTED IN A RADIATION DOSE THAT MOST LIKELY EXCEEDED 1000 RADS, BEST CURRENT ESTIMATE. THE PT WENT INTO CARDIAC ARREST DURING THE PROCEDURE AND REQUIRED RESUSCITATION AND DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-PLANE SPECIAL PROCEDURES FLUOROSCOPE C-ARM FLUOROSCOPE JAA GE MEDICAL SYSTEMS ADVANTX FLUOROSCOPE *
    2 BI-PLANE SPECIAL PROCEDURES FLUOROSCOPE C-ARM FLUOROSCOPE JAA GE MEDICAL SYSTEMS ADVANTX FLUOROSCOPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other DEFIBRILLATION EQUIPMENT.