BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES C TRANSMITTER

    MDR report key: 632058 · Received August 4, 2005

    Report

    Report Number
    632058
    Event Type
    Other
    Date Received
    August 4, 2005
    Date of Event
    August 1, 2005
    Report Date
    August 4, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS INC.
    Product Code
    DRG
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    CLINICAL STAFF IN THE CVU INFORMED CLINICAL ENGINEERING THAT THEY WERE OBSERVING MULTIPLE CASES OF SIGNAL LOSS ON ALL OF THEIR PATIENTS ON TELEMETRY. IT WAS EVIDENT UPON INVESTIGATION THAT THE SIGNAL WAS DROPPING OUT INTERMITTENTLY WHEN OBSERVING THE PATIENT WAVEFORM AT THE CENTRAL STATION.THERE MAY BE ENVIRONMENTAL FACTORS INFLUENCING THE OPERATION OF THE TELEMETRY TRANSMITTERS. THE PHILIPS ENGINEER CALLED TO INVESTIGATE THIS PROBLEM DESCRIBED SOMETHING KNOWN AS THE HETERODYNE EFFECT IN WHICH RANDOM RF SIGNALS IN THE ENVIRONMENT CAN LATCH ONTO A TELEMETRY CHANNEL CAUSING INTERMITTENT RF LOSS ON ONE OR SEVERAL CHANNELS IN A SMALL BANDWIDTH. SPECIAL EQUIPMENT WOULD NEED TO BE BROUGHT IN TO TRACE THE CAUSE OF THIS RF NOISE WHICH CAN BE EMANATING FROM ANYWHERE IN THE BUILDING THAT TELEMETRY ANTENNAS ARE INSTALLED. IF WE COULD TRACE THE SOURCE OF THE RF INTERFERENCE IT IS POSSIBLE THAT IT COULD BE ELIMINATED. HOWEVER, IT IS EASIER TO SIMPLY REPROGRAM THE FREQUENCY OF THE TRANSMITTERS AND MONITOR THEM FOR ANY RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES C TRANSMITTER TELEMETRY TRANSMITTER DRG PHILIPS MEDICAL SYSTEMS INC. M2601A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *