BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ

    MDR report key: 1062161 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00009
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    April 11, 2007
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN INCIDENT WHERE THE TELEMETRY TRANSMITTER GOT WET, THE TRANSMITTER BEGAN OPERATING ON THE WRONG RADIO FREQUENCY CHANNEL. (I.E. A FREQUENCY OTHER THAN THE FREQUENCY ON WHICH IT HAD BEEN PROGRAMMED TO TRANSMIT). WHEN THIS OCCURS, IF A TELEMETRY RECEIVER HAS BEEN TUNED TO ALSO RECEIVE TRANSMISSIONS ON THIS WRONG CHANNEL, THE PT'S WAVEFORM DATA WOULD BE DISPLAYED ON THE CENTRAL MONITOR AS HAVING BEEN TRANSMITTED ON THIS WRONG CHANNEL. INVESTIGATION DETERMINED THE FREQUENCY ASSIGNING SWITCH WAS DEFECTIVE AND REPLACED. REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS INCIDENT TO THE FDA.

    Description of Event or Problem · 1

    BIOMEDICAL ENGINEER REPORTED THAT A MODEL 91341 TELEMETRY TRANSMITTER THAT WAS SET TO TRANSMIT ON CHANNEL #1642 BECAME WET AND SUBSEQUENTLY TRANSMITTED ON TELEMETRY CHANNEL #1640. AFTER THE TRANSMITTER SAT UNUSED FOR ONE HR, THE TRANSMITTER REVERTED BACK TO ITS INTENDED SETTING OF CHANNEL #1642.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ NONE DSI SPACELABS HEALTHCARE 91341

    Patients

    Seq Age Sex Outcome Treatment
    1