BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 3821293 · Received April 16, 2014

    Report

    Report Number
    1720753-2014-03351
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE SERVICE REPRESENTATIVE REPAIR THE SYSTEM AND REQUESTED DE-INSTALLATION OF THE EQUIPMENT. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN INTERLOCK FAILURE. FURTHER INFO FOUND THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234227 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1