BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ

    MDR report key: 1062154 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00010
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    November 27, 2007
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Removal / Correction Number
    Z-1202-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. WE ARE NOW REPORTING THIS ISSUE AS REQUIRED BY 21 CFR 803. HOWEVER, THIS ISSUE WAS REPORTED AS REQUIRED BY 21 CFR 806. 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 PT'S WAVEFORM WOULD BE DISPLAYED ON THE CENTRAL MONITOR AS HAVING BEEN TRANSMITTED ON THIS WRONG CHANNEL. THE RECALL CORRECTIVE ACTION IMPLEMENTED TO RESOLVE THE CHANNEL SWITCHING ISSUE HAS BEEN DETERMINED TO BE INEFFECTIVE. WE WILL EXPAND THE RECALL TO IMPLEMENT A SECONDARY CORRECTIVE ACTION, PENDING RESPONSE TO OUR PROPOSAL FROM THE FDA RECALL COORDINATOR.

    Description of Event or Problem · 1

    BIOMED REPORTED THAT THE TELEMETRY TRANSMITTER SET TO TRANSMIT ON CHANNEL #1023 CHANGED FREQUENCY CAUSING THE PT'S WAVEFORM DATA TO BE RECEIVED BY THE TELEMETRY RECEIVER FOR CHANNEL #1022. THE PROBLEM WAS DISCOVERED BY A MONITOR TECH BEFORE MEDS WERE GIVEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1