BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 3960175 · Received June 24, 2014

    Report

    Report Number
    1044475-2014-00176
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLADE (MAC 4) DOES NOT LIGHT UP. THE ALLEGED DEFECT OCCURRED DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367190 RUSCH MRI COND FIBER OPTIC LARYN KIT MRI LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1