BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 4883781 · Received July 1, 2015

    Report

    Report Number
    1044475-2015-00215
    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 MRI KIT WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE MAC 2 BLADE WAS MISSING. THE COMPLAINT WAS REPORTED AS THE MAC 2 BLADE WOULD NOT ENERGIZE WHEN ENGAGED ON THE HANDLE. THE MAC 2 BLADE WAS NOT PRESENT IN THE KIT; HOWEVER, DURING FUNCTIONAL TESTING OF ALL OF THE RETURNED BLADES, IT WAS FOUND THAT TWO OF THE BLADES WOULD NOT ENERGIZE: THE MAC 3, AND THE MIL 1. THE SMALL INCANDESCENT BULBS WHICH ARE SEATED IN THE FOCS LIGHT BUNDLE WERE EITHER DEFECTIVE OR BURNED OUT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT THE BLADE THAT WAS REPORTED DEFECTIVE WAS NOT RETURNED, BUT THERE WERE DEFECTIVE BLADES IN THE KIT. THE ROOT CAUSE AS TO WHY THE BULBS BURNED OUT COULD NOT BE DETERMINED. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED, HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.

    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
    424325 RUSCH MRI COND FIBER OPTIC LARYN KIT MRI LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL 132601

    Patients

    Seq Age Sex Outcome Treatment
    1