BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1781132 · Received July 29, 2010

    Report

    Report Number
    1720753-2010-02227
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ORDERED A HAND SWITCH FOR THE CUSTOMER TO REPLACE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT PRODUCE X-RAYS FROM THE HANDSWITCH AND DISPLAYED A SWITCH SECURITY ERROR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1