BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVU REUSABLE 3.5" VIDEO LARYNGOSCOPE

    MDR report key: 18874500 · Received March 11, 2024

    Report

    Report Number
    3006061749-2024-00007
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    December 6, 2023
    Report Date
    March 11, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT AS DESCRIBED BY COMPLAINANT: VIDEO WENT OUT ON 2 UNITS WHILE BEING USED ON A PATIENT. I SPOKE TO CUSTOMER AND BOTH PATIENTS WERE EVENTUALLY INTUBATED. "1) I HAD IT ON A CODE AND THE BATTERY WAS AT 86% BUT THE LIGHT ON THE BLADE WOULD BE ON FOR A SECOND AND THEN SHUT OFF. IT WAS ON A MAC 4 AND THEN I TESTED IT ON A DIFFERENT MAC 3 AND IT DID THE SAME THING. I HAVE THIS CAMERA IN MY POSSETION, I HAVE CHARDEG IT FULLY (I RECEIVED IT DEAD) AND HAVE TESTED IT WITH BLADES I HAVE HERE FOR TRAINING, AND IT IS WORKING. I AM UNABLE TO REPLICATE THE PROBLEM. 2) TONIGHT WHILE ON A CALL IN THE MIDDLE OF INTUBATION, THE SCREEN WENT BLYE WITH ERROR MESSAGES. WE TOOK THE SCREEN OFF, PUT IT BACK AND IT GAVE THE SAME ERROR. WE TOOK TI OFF ONE MORE TIME AND PUT IT BACK AND IT WORKED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457313 PROVU REUSABLE 3.5" VIDEO LARYNGOSCOPE VIDEO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown