BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC BATTERY

    MDR report key: 3960569 · Received June 24, 2014

    Report

    Report Number
    1044475-2014-00180
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT DURING AN INTUBATION ATTEMPT WITH THE MRI LARYNGOSCOPE; THE LIGHT FAILED AND THE PATIENT WAS INTUBATED WITHOUT LIGHT. THE BATTERY WILL WORK INTERMITTENTLY. NO REPORT OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368100 RUSCH MRI COND FIBER OPTIC BATTERY BATTERY PACK CAL TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1