BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRITEPRO OMNI

    MDR report key: 19527532 · Received June 13, 2024

    Report

    Report Number
    3006061749-2024-00023
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 25, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** AT TIME OF RECEIVING THE EVENT DETAIL THE UDI INFORMATION WAS NOT SUBMITTED TO US; WE HAVE THE PART NUMBER AND LOT NUMBER WHICH ARE INCLUDED IN THE EVENT SUBMISSION.

    Description of Event or Problem · 0

    AS DESCRIBED BY COMPLAINEE- ''MD REQUESTED A MAC 4. MAC 4 USED DURING INTUBATION HAVING LIGHT GO OFF WITH MINIMAL PRESSURE. 6/6 ADDITIONAL EVENT INFORMATION- EVENT OCCURED WHEN IN USE IN PATIENTS MOUTH. WHEN APPLIED PRESSURE TO LIFT, LIGHT TURNED OFF. THEY INTUBATED PATIENT WITH A DIFFERENT OMNI, UNSURE OF LOT NO. NO ADVESE PATIENT OUTCOME.''

    Description of Event or Problem · 0

    AS DESCRIBED BY COMPLAINEE- ''MD REQUESTED A MAC 4. MAC 4 USED DURING INTUBATION HAVING LIGHT GO OFF WITH MINIMAL PRESSURE. 6/6 ADDITIONAL EVENT INFORMATION- EVENT OCCURED WHEN IN USE IN PATIENTS MOUTH. WHEN APPLIED PRESSURE TO LIFT, LIGHT TURNED OFF. THEY INTUBATED PATIENT WITH A DIFFERENT OMNI, UNSURE OF LOT NO. NO ADVESE PATIENT OUTCOME.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124671 BRITEPRO OMNI LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD 230901214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown