BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 5075258 · Received September 14, 2015

    Report

    Report Number
    1044475-2015-00371
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 2, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE PREPARING FOR PATIENT INTUBATION A BLADE WAS ATTACHED AND ENGAGED ON THE MRI HANDLE THAT WOULD NOT LIGHT. A STANDARD LARYNGOSCOPE SET WAS USED. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE PREPARING FOR PATIENT INTUBATION A BLADE WAS ATTACHED AND ENGAGED ON THE MRI HANDLE THAT WOULD NOT LIGHT. A STANDARD LARYNGOSCOPE SET WAS USED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607375 RUSCH MRI COND FIBER OPTIC LARYN KIT MRI LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1