BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TE

    MDR report key: 2040369 · Received February 15, 2011

    Report

    Report Number
    9617494-2011-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 15, 2011
    Manufacturer
    GMS-GESELLSCHAFT FUR MEDIZINISHE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMPERATURE CATHETER INDICATED AT THE BEGINNING A VERY HIGH VALUE. THE VALVE DID NOT DROP. THE PRODUCT WAS IN CONTACT WITH THE PT AND THERE WAS NO PT INJURY OR DEATH AS A RESULT OF THIS EVENT. THE EVENT LEAD TO AN INCREASE IN SURGERY TIME OF 1 HOUR. THE CATHETER WAS EXCHANGED FOR A NEW WHICH WORKED WELL. THE PROCEDURE DONE DURING THE INCIDENT WAS A TRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TE NA GWM GMS-GESELLSCHAFT FUR MEDIZINISHE 110310SN763

    Patients

    Seq Age Sex Outcome Treatment
    1