BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRITEPRO SOLO

    MDR report key: 6519220 · Received April 25, 2017

    Report

    Report Number
    6519220
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 27, 2017
    Report Date
    April 5, 2017
    Manufacturer
    FLEXICARE, INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER A (B)(6) GESTATION, A (B)(6) INFANT WAS BEING RESUSCITATED IN THE NICU RESUSCITATION ROOM ON LABOR AND DELIVERY. WE ARE NOW USING DISPOSABLE FLEXICARE LARYNGOSCOPE HANDLES MADE BY FLEXICARE. THE INFANT REQUIRED INTUBATION. UPON BEGINNING THE INTUBATION ATTEMPT, AND WITH THE LARYNGOSCOPE BLADE IN INFANT'S MOUTH, THE NEONATAL NURSE PRACTITIONER (NNP) NOTICED WEAK LIGHT SOURCE, AND FLICKERING ON AND OFF OF LIGHT. THE INTUBATION ATTEMPT HAD TO BE ABANDONED. INFANT HAD BRIEF PERIOD OF BRADYCARDIA DOWN TO 70'S AND DESATURATION DOWN TO 50'S UNTIL VENTILATION WITH NEOPUFF MASK WAS RE-ESTABLISHED. A NEW HANDLE WAS PULLED FROM SUPPLY AND USED WITH SAME 00 BLADE AS FIRST ATTEMPT. THE LIGHT SOURCE WAS MUCH BRIGHTER; WE WERE ABLE TO PROCEED WITH INTUBATION. THE FIRST HANDLE USED IS SEQUESTERED IN NICU. THIS (B)(6) INFANT IS AT HIGHEST RISK FOR SEVERE MORBIDITY IN THE NICU DUE TO PERI-VIABLE GESTATIONAL AGE AND REPEAT INTUBATION ATTEMPTS HAVE BEEN THEORIZED TO BE A RISK FACTOR FOR AIRWAY INJURY OR INTRA-VENTRICULAR HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300054 BRITEPRO SOLO LARYNGOSCOPE, RIGID CCW FLEXICARE, INC. 040-309U 161001836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR NO