BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2250051-2009-00032

    MDR report key: 1321010 · Received January 30, 2009

    Report

    Report Number
    2250051-2009-00032
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Product Code
    JTC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE PLUNGER CLAMP IN POSITION 4 WITH A STUCK EJECTION PIN. FSE ALSO REPLACED TIP CLAMP IN POSITION 3 WITH BENT PRONG. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM, AND WAS RETURNED TO EXPECTED OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JTC

    Patients

    Seq Age Sex Outcome Treatment
    1