BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL ADULT NASAL CANNULA 2.1M

    MDR report key: 19679697 · Received July 5, 2024

    Report

    Report Number
    3006061749-2024-00026
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 5, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT AS DESCRIBED BY COMPLAINANT: 'WHEN USING AN ORAL AIRWAY, THE O2 DELIVERY PORTION IS NOT DELIVERING ENOUGH O2 THROUGH THE AIRWAY. AFTER SPEAKING WITH THE ANESTHESIA PROVIDER, HE SAID THAT THE PATIENTS ARE DE-SATING WHEN THEY ARE IN DEEP ANESTHESIA. THE PROVIDERS ARE HAVING TO USE NONREBREATHER MASKS OR PUT THE MASK FROM THE ANESTHESIA CIRCUIT OVER THE PATIENTS MOUTH WITH THE O2 CANNULA IN THE MOUTH OR ORAL AIRWAY TO GET THEIR SATS UP'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282145 DUAL ADULT NASAL CANNULA 2.1M NASAL CANNULA CAT FLEXICARE MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown