BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 194627 · Received October 28, 1998

    Report

    Report Number
    1720753-1998-00013
    Event Type
    Injury
    Date Received
    October 28, 1998
    Date of Event
    October 23, 1998
    Report Date
    October 27, 1998
    Manufacturer
    OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 10/26/1998 OEC MEDICAL SYSTEMS INC WAS NOTIFIED THAT AN INJURY OCCURRED TO A PT DURING A PROCEDURE THAT UTILIZED AN OEC MODEL 9600 SERIES C-ARM. DURING A PROCEDURE THE DR ATTEMPTED TO MOVE THE C-ARM, BUT INSTEAD OF GRABBING THE HANDLES ON THE IMAGE INTENSIFIER, THE DR GRABBED THE RELEASE LEVER OF THE ATTACHED LASER AIMER DEVICE. THE LASER AIMER DISENGAGED AND FELL ONTO THE PT. THE PT REQUIRED MEDICAL INTERVENTION. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT FURTHER INCIDENT. AN OEC FIELD SVC ENGINEER TESTED/INSPECTED THE SYSTEM AND FOUND NO DEFECTS OR MALFUNCTION. OEC ATTRIBUTES THIS INCIDENT TO OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM MOBIL C-ARM SERIES 9600 JAA OEC MEDICAL SYSTEMS 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention