BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 3929932 · Received March 10, 2014

    Report

    Report Number
    1044475-2014-00068
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    TELEFLEX
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE BLADES DO NOT ILLUMINATE AT ALL TIMES AND SOME DO NOT FUNCTION AT ALL. THE ALLEGED ISSUES WAS DETECTED DURING TESTING OF THE DEVICE. THE CUSTOMER REPORTS THAT THEY DISPOSED OF TWO BATTERIES THAT WERE NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143603 RUSCH MRI COND FIBER OPTIC LARYN KIT LARYNGOSCOPE KIT OGH TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1