BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRTRAQ

    MDR report key: 17499377 · Received August 9, 2023

    Report

    Report Number
    MW5122885
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    August 5, 2023
    Report Date
    August 7, 2023
    Manufacturer
    PRODOL MEDITEC LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AIRTRAQ CAMERA FAILURE DURING RAPID SEQUENCE INTUBATION. NO PATIENT HARM AS A SECONDARY MEANS OF INTUBATION WAS MAD READY PRIOR TO THE ATTEMPT AND TRANSITIONED TO IMMEDIATELY FOLLOWING THE FAILURE. AIRWAY PATENCY CONFIRMED BY AGENCY PROTOCOL MEASURES DETAILED IN EHR REPORT. THIS WAS SECONDARILY CONFIRMED BY THE RECEIVING FACILITY. MONITOR SERVICED AND CHECKED BY COMPLIANCE OFFICER FOR PHYSICAL DAMAGE. POSSIBLE NORMAL USE DEGRADATION OF O-RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050047 AIRTRAQ LARYNGOSCOPE, RIGID CCW PRODOL MEDITEC LIMITED AIRTRAQ 20593

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other