BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 16768163 · Received April 19, 2023

    Report

    Report Number
    16768163
    Event Type
    Death
    Date Received
    April 19, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 10, 2023
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, DURING USE OF AN OSCILLATING VENTILATOR, SOMEHOW THE CIRCUIT CAME LOOSE AT THE CONNECTION BETWEEN 22MM ADAPTOR AND THE ONE-WAY VALVE. THE CIRCUIT WAS SETUP CORRECTLY, THERE WAS NO APPRECIATED DEVICE DEFECT, AND A CONNECTION ISSUE COULD NOT BE REPLICATED WHEN THE VENTILATOR AND THE SAME BRAND AND TYPE OF CIRCUIT WAS USED UPON A POST-EVENT EVALUATION. THE PT INVOLVED IN THIS EVENT EXPERIENCED APPROX A 30-SECOND TIMEFRAME OF THE VENTILATOR ALARMING BEFORE THE DISCONNECTED CIRCUIT WAS DISCOVERED AND CORRECTED. THE PT EXHIBITED BRADYCARDIA FOLLOWED BY A PEA ARREST AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273296 MALLINCKRODT ONE-WAY VALVE 22F X 22M BZO MALLINCKRODT PHARMACEUTICALS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Death| L