BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 4627814 · Received March 20, 2015

    Report

    Report Number
    1044475-2015-00140
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 24, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DEVICE DOES NOT WORK. THE ALLEGED ISSUE DETECTED DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192063 RUSCH MRI COND FIBER OPTIC LARYN KIT LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1