BEUDAMED
    FDA Adverse Event Other Summary report: N

    GREENLINE FIBEROPTIC LARYNGOSCOPE BLADE

    MDR report key: 2711118 · Received August 17, 2012

    Report

    Report Number
    MW5026584
    Event Type
    Other
    Date Received
    August 17, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 17, 2012
    Manufacturer
    DRE MEDICAL
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(4) REPRESENTED THAT ITS LARYNGOSCOPE BLADES COULD BE USED WITH BOTH GREENLINE AND RUSCH FIBEROPTIC LARYNGOSCOPE HANDLES. WE HAVE BOTH HANDLES IN OUR INSTITUTION, AND WE HAVE GREENLINE LARYNGOSCOPE BLADES. GREENLINE RECENTLY MODIFIED ITS BLADES, WHICH RESULTED IN THE BLADES ONLY WORKING WITH GREENLINE'S HANDLES. WE WERE AWARE OF THE MODIFICATION TO THE BLADES, BUT WERE ASSURED THE MODIFIED BLADES WOULD WORK WITH GREENLINE AND RUSCH HANDLES. DURING INTUBATION OF A NEWBORN, WE ATTEMPTED TO USE A GREENLINE BLADE WITH A RUSCH HANDLE AND IT WOULD NOT LOCK INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLINE FIBEROPTIC LARYNGOSCOPE BLADE LARYNGOSCOPE BLADE CAL DRE MEDICAL G-MILLER 0 BLADE LC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other