BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLINE D

    MDR report key: 2052779 · Received April 6, 2011

    Report

    Report Number
    2052779
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 3, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SUNMED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER WAS ATTEMPTING TO INTUBATE A PATIENT DURING A CARDIAC ARREST WITH A MILLER 3 BLADE THAT WAS PROPERLY CONNECTED TO THE HANDLE. WHEN LIFTING UP ON THE HANDLE, THE BLADE'S PLASTIC CONNECTOR TO HANDLE BROKE CAUSING BLADE TO FALL OFF THE HANDLE AND BECOME INSUFFICIENT TO USE FOR INTUBATION. ANOTHER BLADE WAS USED CAUSING A SLIGHT DELAY IN INTUBATION, BUT NO ADVERSE EFFECT TO PATIENT. THERE WAS A SIMILAR OCCURRENCE IN (B) (6) 2010 AND SO WE ARE IN THE PROCESS OF SELECTING A NEW PRODUCT.SUN-MED REQUESTED THAT BOTH LARYNGOSCOPE BLADES BE SHIPPED TO THEM. WE WILL SHIP BOTH LARYNGOSCOPE BLADES TO SUN-MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLINE D DISPOSABLE LARYNGOSCOPE BLADE CCW SUNMED MILLER 3 01N

    Patients

    Seq Age Sex Outcome Treatment
    1 *