BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TE

    MDR report key: 1942110 · Received November 11, 2010

    Report

    Report Number
    9617494-2010-00004
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    GMS
    Product Code
    DRF
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AN LICOX OXYGEN MICRO-PROBE DEVELOPED A MALFUNCTION AND WAS DESCRIBED AS; THE CUSTOMER PUT IN THE CATHETER AND THE READING WAS 127. THIS VALUE NEVER FELL TO A NORMAL VALUE AND IT DID NOT INCREASE WHEN THEY PERFORMED A OXYGEN CHALLENGE. THE CUSTOMER CHANGED THE MONITOR, HE TURNED IT ON AND OFF AND IT STILL SHOWED A HIGH VALUE. THERE WAS PT CONTACT, BUT NO INJURY AND IT IS UNK WHETHER THERE WAS A DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TE NA DRF GMS 240610

    Patients

    Seq Age Sex Outcome Treatment
    1