BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PO2 MICROPROBE 200 MM WITH SMART CARD

    MDR report key: 2190936 · Received July 19, 2011

    Report

    Report Number
    9617494-2011-00006
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GMS-GESELLSCHAFT FUR MEDIZINISCHE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    IT WAS REPORTED THAT A HIGH NUMBER OF CC1 PROBES (PO2 MICROPROBE 200MM WITH SMART CARD) WERE SHOWING ZERO AFTER BEING IMPLANTED FOR PLASTIC SURGERY (FLAP MONITORING). IT WAS NECESSARY TO IMPLANT UP TO THREE PROBES PER PT UNTIL A VALID VALUE WAS SEEN ON THE MONITOR. THERE WAS NO PT IMPACT AS A RESULT OF THESE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PO2 MICROPROBE 200 MM WITH SMART CARD NA GWM GMS-GESELLSCHAFT FUR MEDIZINISCHE 310111

    Patients

    Seq Age Sex Outcome Treatment
    1