BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 11012774 · Received December 15, 2020

    Report

    Report Number
    2936999-2020-00928
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MALLINCKRODT DAR SRL
    Product Code
    CAH
    UDI-DI
    20884522033319
    PMA / PMN Number
    K941676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER PATIENT WAS EMERGING FROM ANESTHESIA, ETCO2 WAS LOST AND O2 SATURATION DROPPED PRECIPITOUSLY. IT WAS UNABLE TO MOVE GASES THROUGH FILTER DUE TO SUSPECTED CLOGGING WITH SECRETIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477139 DAR FILTER, BACTERIAL, BREATHING-CIRCUIT CAH MALLINCKRODT DAR SRL 351U5979 20884522033319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention