BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1934405 · Received November 24, 2010

    Report

    Report Number
    1720753-2010-04317
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 24, 2010
    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 CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6600 SYSTEM HAD THE X-RAY ALARM GOING OFF INTERMITTENTLY DURING A CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1