BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2241113 · Received August 17, 2011

    Report

    Report Number
    1720753-2011-21125
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PROVIDED OVER THE PHONE TECHNICAL SUPPORT FOR THE CUSTOMER AND ANSWERED QUESTIONS REGARDING THE SRAM. THE CUSTOMER REPORTED THE SYSTEM WAS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYSTEM'S WORKSTATION TURNED ON BUT THE C-ARM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1