BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGUIRE INTERCONNECT ALARM

    MDR report key: 20693847 · Received November 15, 2024

    Report

    Report Number
    20693847
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 1, 2024
    Manufacturer
    MAGUIRE ENTERPRISES, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ASTRAL VENT CORDS: THE CORDS ARE A POOR DESIGN. THERE IS A 5-PIN CONNECTOR ON THE VENT TO WHICH THE CABLE'S PLUG CONNECTS. THE PLUG IS TINY AND KEYED, MAKING IT DIFFICULT TO LINE UP AS YOU PLUG IT IN. WHEN UNPLUGGING, MOST PEOPLE WILL PULL ON THE CORD RATHER THAN THE PLUG ITSELF. THE PLUG IS SMALL AND WILL DAMAGE THE SOLDER JOINTS INSIDE THE CONNECTOR, TEARING IT OFF THE CABLE. PER RESMED: THE PLUG WAS INTENTIONALLY DESIGNED TO BE DIFFICULT TO REMOVE FROM THE BACK OF THE DEVICE SO THAT IT WOULDN'T ACCIDENTALLY BE PULLED OUT AND PUT THE PATIENT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186813 MAGUIRE INTERCONNECT ALARM CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA MAGUIRE ENTERPRISES, INC. ME590153E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose