BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2090705 · Received April 26, 2011

    Report

    Report Number
    1720753-2011-06597
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2600 SYSTEM HAD A DAMAGED INTERCONNECT CABLE. 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