BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2041380 · Received March 23, 2011

    Report

    Report Number
    1720753-2011-02654
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY TRANSISTOR REQUIRED REPLACEMENT, HOWEVER, THE PART WAS NOT AVAILABLE. REPLACEMENT WAS REFERRED TO THE CUSTOMER. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 2600 SYSTEM WOULD NOT FLUORO, HOWEVER, FILM SHOTS WERE GOOD. NO PT INJURY WAS REPORTED.

    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