BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOLYTH INTEGRATED MEMBRANE LUNG

    MDR report key: 225269 · Received May 25, 1999

    Report

    Report Number
    2022323-1999-00011
    Event Type
    Malfunction
    Date Received
    May 25, 1999
    Date of Event
    April 23, 1999
    Report Date
    May 25, 1999
    Manufacturer
    SORIN BIOMEDICAL INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONOLYTH OXYGENATORS WERE REPORTED TO HAVE HAD LOW PO2 READINGS. BOTH WERE CHANGED OUT WITHOUT PROBLEMS AND THE PROCEDURES CONTINUED WITHOUT FURTHER INCIDENT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOLYTH INTEGRATED MEMBRANE LUNG MONOLYTH OXYGENATOR DTZ SORIN BIOMEDICAL INC. M302 983562

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention