BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2100

    MDR report key: 1190708 · Received October 6, 2008

    Report

    Report Number
    9611343-2008-00050
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 6, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K050489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR TABLE-ANCHORING BOLT THAT IS FASTENED TO THE FLOOR BECAME LOOSE AND THE TABLE TILTED DURING AN EXAM. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1