BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION

    MDR report key: 19141775 · Received April 19, 2024

    Report

    Report Number
    3006061749-2024-00018
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 19, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT AS DESCRIBED BY COMPLAINANT: THE PROVU MONITOR FREEZES AND BLINKS DURING INTUBATIONS. WHEN A NEW AMPLIFIER CABLE WAS USED, THE SCREEN WAS STILL GLITCHING. THE SCREEN THEN DISPLAYED AN INTERNAL ERROR. ANOTHER PROVU STAND WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057526 PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION VIDEO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD XUPD60968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown