BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH STANDARD HANDLE MEDIUM

    MDR report key: 3834542 · Received March 19, 2014

    Report

    Report Number
    1044475-2014-00062
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CUSTOMER ALLEGES THAT THE HANDLE WILL NOT LIGHT WHEN CONNECTED TO THE RUSCH EQUIP-LITE BLADE. THE HANDLE WAS BEING PRETESTED AT THE TIME OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163427 RUSCH STANDARD HANDLE MEDIUM LARYNGOSCOPE HANDLE CCW TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1