BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVU

    MDR report key: 19191667 · Received April 26, 2024

    Report

    Report Number
    3006061749-2024-00019
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 26, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE EVENT DETAILS AS REPORTED TO MANUFACTURING " THIS WAS A CRITICAL CASE, PATIENT WITH PANCREATIC CANCER WITH STRONG SUSCEPTIBILITY TO BLEEDING. WHEN GOING INTO INTUBATE, THE PROVU 8" MONITOR SCREEN BLACKED AND NO LONGER DISPLAYED VIDEO. THEY RETRACTED THE BLADE, DECOMMISSIONED THE MONITOR, BEGAN BAGGING THE PATIENT AND OBTAINED A FUNCTIONING PROVU 3.5" MONITOR TO INTUBATE WITH. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE INTUBATION WITH NO ADVERSE OUTCOME"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308210 PROVU VIDEO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown