BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2090506 · Received April 26, 2011

    Report

    Report Number
    9680959-2011-01108
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE FILTER BOARD NEEDS TO BE REPLACED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7700 SYSTEM WOULD NOT OVERHEAT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1