BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRITEPRO SOLO

    MDR report key: 16973973 · Received May 22, 2023

    Report

    Report Number
    3006061749-2023-00014
    Event Type
    Death
    Date Received
    May 22, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 10, 2023
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE "DEATH" HAS BEEN REPORTED. THIS WAS NOT ATTRIBUTED TO THE LARYNGOSCOPE DEVICE ERROR - SEE BELOW FOR CLINICIANS COMMENTS: "PATIENT DIED/WAS DEAD, RESUSCITATION FAILED. CLINICIAN COULD NOT STATE THAT THE DEFECT LARYNGOSCOPE CAUSE THE FAILURE OF RESUSCITATION. THERE WAS A SMALL DELAY IN INTUBATION."

    Description of Event or Problem · 0

    EVENT OCCURED AS DESCRIBED BELOW BY COMPLAINANT - "ACUTE HEART ARREST/RESUCITATION - BO LIGHT IN THE LARYNGOSCOPE. FOUND ANOTHER ONE FROM THE SAME LOT THAT WORKED." CLINICIANS ADDITONAL COMMENTS AS BELOW - "PATIENT DIED/WAS DEAD, RESUCITATION FAILED. CLINICIAN COULD NOT STATE THAT THE DEFECT LARYNGOSCOPE CAUSE THE FAILURE OF RESUCITATION. THERE WAS A SMALL DELAY IN INTUBATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808477 BRITEPRO SOLO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD 190800671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown