BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOSURE

    MDR report key: 2971592 · Received January 23, 2013

    Report

    Report Number
    2971592
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, THE INSUFFLATOR STATED OVER PRESSURE, AND WAS VENTING. AT THE PROCEDURE'S END, ANESTHESIA NOTED THAT THE PATIENT'S CARBON DIOXIDE (CO2) LEVEL INCREASED AND THE PATIENT HAD A PROLONGED WAKE UP LASTING 95 MINUTES. THE PATIENT WAS AWAKENED IN THE OPERATING ROOM. THE INSUFFLATOR WAS REMOVED FROM SERVICE AND SENT TO BIOMED DEPARTMENT. THE PHYSICIAN WAS NOTIFIED/AWARE OF THE EVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC VENTRAL HERNIA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33828 PNEUMOSURE INSUFFLATOR, LAPAROSCOPIC HIF STRYKER MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR