BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS,LHK,CEDARS,SINAI

    MDR report key: 19962682 · Received August 12, 2024

    Report

    Report Number
    3015910259-2024-00028
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 16, 2024
    Report Date
    March 23, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    QEZ
    UDI-DI
    20193489104957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A MANIFOLD THAT WAS UTILIZED WHERE THE CHAMBER/BALL WAS MISSING. IT WAS REPORTED THAT AIR DID GET IN THE LINE AND THE AIR WAS EMBOLIZED INTO THE CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE MADE TO: D3.

    Description of Event or Problem · 0

    MANIFOLD DIDN'T INCLUDE THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350647 MTS,LHK,CEDARS,SINAI QEZ MEDLINE INDUSTRIES, LP - NAMIC 0000123860 20193489104957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other