BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 4884497 · Received July 1, 2015

    Report

    Report Number
    1044475-2015-00216
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 18, 2014
    Report Date
    June 17, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425903 RUSCH MRI COND FIBER OPTIC LARYN KIT MRI LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL 132601

    Patients

    Seq Age Sex Outcome Treatment
    1