BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 3908708 · Received May 5, 2014

    Report

    Report Number
    1044475-2014-00130
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    TELEFLEX
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT USAGE WHEN ALLEGED DEFECT WAS ENCOUNTERED IS UNK AT THE TIME OF THIS REPORT. IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE LARYNGOSCOPE DID NOT LIGHT UP. WHEN THE TECH ATTEMPTED TO REMOVE THE BATTERY, THE TAB WAS EITHER ALREADY BROKEN IN THE HANDLE OR IT BROKE DURING EXTRACTION OF THE BATTERY. NO REPORT OF PT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268685 RUSCH MRI COND FIBER OPTIC LARYN KIT LARYNGOSCOPE KIT OGH TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1