BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 3100

    MDR report key: 1438188 · Received February 3, 2009

    Report

    Report Number
    9611343-2009-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Report Date
    February 3, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN EXAMINATION, THE RT MOVED THE MONITOR SUSPENSION. ONE SIDE OF THE CURTAIN RAIL HOLDING THE MONITOR CABLE DROPPED SUDDENLY. NO INJURY WAS REPORTED. A GE FIELD SERVICE ENGINEER DISCOVERED THAT ONE OF THE RAIL MOUNTING SCREWS WAS LOOSE. THE CURTAIN RAIL WAS REPAIRED. 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 3100 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1