BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ

    MDR report key: 1062156 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00007
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    March 9, 2007
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Removal / Correction Number
    Z-1202-6
    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 IN WHICH, UPON BEING POWERED UP, A TELEMETRY TRANSMITTER WOULD BEGIN TRANSMITTING ON THE WRONG RADIO FREQUENCY CHANNEL (I.E. 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 PATIENT'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. ADDITIONAL SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    BIOMED (B)(6) REPORTED THAT A PT WEARING A MODEL 91341 TELEMETRY TRANSMITTER THAT WAS SET TO CHANNEL #1688 WAS DISCHARGED AND THE BATTERY WAS REMOVED FROM THE TRANSMITTER. ANOTHER PT WEARING A DIFFERENT TELEMETRY TRANSMITTER SET TO CHANNEL #1689, WENT TO A PROCEDURE AND THE BATTERY WAS REMOVED FROM THE TRANSMITTER. WHEN THE PT RETURNED, THE BATTERY WAS REINSERTED INTO THE TRANSMITTER WHICH THEN IMPROPERLY BEGAN TRANSMITTING ON CHANNEL #1688. (B)(6) INDICATED THE BATTERY WAS REMOVED AND THE TRANSMITTER WAS TESTED, THE SIGNAL REMAINED ON THE IMPROPER CHANNEL, #1688. MR. MASON THEN RETESTED THE TELEMETRY TRANSMITTER ABOUT TWO HOURS LATER AND IT TRANSMITTED ON THE PROPER CHANNEL, #1689.

    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