BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT MONITOR

    MDR report key: 1882696 · Received October 13, 2010

    Report

    Report Number
    9610105-2010-00019
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    July 7, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE HEALTHCARE FINLAND, OY
    Product Code
    DRT
    PMA / PMN Number
    K981378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTED THAT A PT'S OXYGEN LEVEL DECREASED FOLLOWING AN OPERATION, AND THE LIGHT MONITOR DID NOT PROVIDE AN AUDIBLE ALARM. A NURSE ALLEGEDLY SAW THE LOW SPO2 ALARM ON THE MONITOR, BUT DID NOT HEAR THE ALARM. FOLLOWING THE EVENT, THE PT WAS TREATED WITH ADDITIONAL OXYGEN. THE PT RESPONDED TO TREATMENT AND WAS REPORTEDLY DISCHARGED WITHOUT ANY COMPLICATIONS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT MONITOR CARDIAC MONITOR DRT GE HEALTHCARE FINLAND, OY

    Patients

    Seq Age Sex Outcome Treatment
    1