BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRITEPRO SOLO

    MDR report key: 20871215 · Received December 6, 2024

    Report

    Report Number
    3006061749-2024-00038
    Event Type
    Death
    Date Received
    December 6, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 6, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE REACHED OUT TO THE FACILITY TO GATHER MORE INFORMATION REGARDING THE EVENTS DESCRIBED. THE COMPLAINANT DOES NOT BELIEVE THE CAUSE OF DEATH IS LIMITED TO THE FAILURE OF THE DEVICE, AND THAT THE SECOND PATIENT WAS ABLE TO BE SUCCESSFULLY INTUBATED BY OTHER MEANS. AT THE TIME OF SUBMISSION WE DO NOT HAVE THE UDI INFORMATION.

    Description of Event or Problem · 0

    THE EVENT WAS DESCRIBED AS: 'ALL IN THE LAST 10 HOURS WE HAVE HAD 5 HANDLES FAIL ALL DURING URGENT EMERGENCY RESUSCITATION PROCEDURES' FURTHER INFRACTION DETAILS '2 PATIENTS INVOLVED. ALL HANDLES WERE STORED ON CRASH CARTS. 1 PATIENT EXPIRED AFTER DELAYED CARE. AFTER BRITEPRO SOLO HANDLES FAILED, A FIBER OPTIC WAS PULLED AS ALTERNATE FORM OF INTUBATION TOOL, WAS ABLE TO INTUBATE PATIENT, BUT PATIENT DID END UP EXPIRING. COMPLAINANT DOES NOT BELIEVE THE CAUSE OF DEATH IS LIMITED TO THE FAILURE OF THE DEVICE BUT THE FAILURE OF DEVICE AND DELAY IN CASE DID MAKE THE SITUATION WORSE. SECOND PATIENT WAS ABLE TO BE SUCCESSFULLY INTUBATED BY OTHER MEANS. TWO PRODUCTS THAT WERE USED ON PATIENTS WERE DISPOSED OF, BUT 3 OF THE HANDLES ARE SAVED AND AVAILABLE FOR RETURN.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471205 BRITEPRO SOLO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death