BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ

    MDR report key: 1062155 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00006
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    April 3, 2007
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS MEDICAL
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Removal / Correction Number
    Z-1202-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS INCIDENT TO THE FDA. THE CUSTOMER REPORTED AN INCIDENT IN WHICH, UPON BEING POWERED UP, A TELEMETRY TRANSMITTER WOULD BEGIN TRANSMITTING ON THE WRONG RADIO FREQUENCY CHANNEL (IE A FREQUENCY OTHER THAN THE FREQUENCY ON WHICH IT HAD BEEN SET TO TRANSMIT). WHEN THIS OCCURS, IF ANOTHER TELEMETRY RECEIVER AT THE SITE HAS BEEN TUNED TO RECEIVE TRANSMISSIONS ON THIS OTHER (WRONG) CHANNEL, THE PT'S WAVEFORM WOULD BE DISPLAYED ON THE CENTRAL MONITOR AS HAVING BEEN TRANSMITTED ON THIS WRONG CHANNEL. PRIOR TO RECEIPT OF THIS COMPLAINT, WE HAD ALREADY INITIATED A RECALL TO ADDRESS PREVIOUSLY REPORTED INCIDENTS OF CHANNEL SWITCHING. AT THE TIME OF THIS COMPLAINT, THIS CUSTOMER'S PRODUCTS HAD NOT YET BEEN UPDATED IN CONNECTION WITH THE RECALL CORRECTIVE ACTION. THIS RECALL IS STILL IN PROCESS.

    Description of Event or Problem · 1

    BIOMED (B) (4) REPORTED THAT THE HOSPITAL HAS HAD ONGOING PROBLEMS WITH MODEL NUMBER 91341, 1.4MHZ TELEMETRY TRANSMITTERS. (B) (4) IS NOW REPORTING THAT A 91341 TELEMETRY TRANSMITTER HAS SIGNED ONTO THE WRONG TELEMETRY RECEIVER MODULE. A TELEMETRY TRANSMITTER WHICH HAD BEEN SET TO CHANNEL #1011, HAD IMPROPERLY SIGNED ON TO THE TELEMETRY RECEIVER SET TO CHANNEL #1010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1