BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOLYTH INTEGRATED MEMBRANE LUNG

    MDR report key: 218573 · Received April 13, 1999

    Report

    Report Number
    2022323-1999-00007
    Event Type
    Malfunction
    Date Received
    April 13, 1999
    Date of Event
    March 18, 1999
    Report Date
    April 13, 1999
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING A MONOLYTH OXYGENATOR THE P02 READING DROPPED. THE UNIT WAS CHANGED OUT WITH ANOTHER MONOLYTH OXYGENATOR WITHOUT INCIDENT AND THE PROCEDURE CONTINUED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOLYTH INTEGRATED MEMBRANE LUNG MEMBRANE OXYGENATOR DTZ SORIN BIOMEDICAL, INC. M302 983329

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention