BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2850333 · Received November 26, 2012

    Report

    Report Number
    1720753-2012-09607
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 26, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. A HARD DRIVE REPLACEMENT KIT WAS ORDERED. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A 253 ERROR MESSAGE WHICH PREVENTED THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1