BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITEPRO SOLO

    MDR report key: 19623633 · Received June 27, 2024

    Report

    Report Number
    3006061749-2024-00025
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 27, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EVENT AS DESCRIBED BY COMPLAINANT: CUSTOMER SAYS THEY WERE IN A CODE AND TRIED INTUBATING A PEDS PATIENT, AND WENT THROUGH 3-4 HANDLES THAT WERE NOT WORKING DURING THE EMERGENT INTUBATION INCIDENT. THERE WAS NO DETECTABLE PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430077 BITEPRO SOLO LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD 200404729, 200902551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown