BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    91341 TELEMETRY TRANSMITTER, 1400 MHZ

    MDR report key: 1135684 · Received August 22, 2008

    Report

    Report Number
    3023361-2008-00040
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    April 27, 2006
    Report Date
    August 22, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN INCIDENT IN WHICH, UPON BEING POWERED UP, A TELEMETRY TRANSMITTER SET TO TRANSMIT ON A CERTAIN FREQUENCY CHANNEL (FOR CLARITY "CHANNEL 1") WOULD BEGIN TRANSMITTING ON THE WRONG RADIO FREQUENCE CHANNEL (FOR CLARITY "CHANNEL 2). WHEN THIS OCCURS, IF ANOTHER TELEMETRY RECEIVER AT THE SITE HAS BEEN TUNED TO RECEIVE TRANSMISSIONS ON THIS OTHER CHANNEL - CHANNEL 2, THE PATIENT'S WAVEFORM WOULD BE DISPLAYED ON THE CENTRAL MONITOR AS HAVING BEEN TRANSMITTED ON CHANNEL 2. PRIOR TO RECEIPT OF THIS COMPLAINT, SPACELABS HAVE INITIATED A RECALL TO ADDRESS PREVIOUSLY REPORTED INCIDENTS OF CHANNEL SWITCHING. AT THE TIME OF THIS COMPLAINT, THE CUSTOMER'S PRODUCTS HAD NOT YET BEEN UPDATED IN CONNECTION WITH THE RECALL CORRECTIVE ACTION. THIS RECALL IS STILL IN PROCESS. NOTE: THIS REPORT IS BEING SUBMITTED AS A RESULT OF A REEVALUATION OF PAST COMPLAINTS BY SPACELABS. ALTHOUGH A REPORT HAD NOT PREVIOUSLY BEEN FILED FOR THIS INCIDENT, WE HAVE CONCLUDED THAT A REPORT IS APPROPRIATE. WE ARE NOW REPORTING THIS INCIDENT IN ACCORDANCE WITH 21 CFR 803. SPACELABS HAD PREVIOUSLY REPORTED THIS CHANNEL SWITCHING ISSUE TO THE FDA PER 21 CFR 806 AS PART OF A CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT A HIGH FAILURE RATE OF 1400 MHZ TRANSMITTERS DURING THE PRIOR YEAR. INVESTIGATION REVEALED THAT THREE OF THE RETURNED TRANSMITTERS EXHIBITED CHANNEL SWITCHING, FOR WHICH SPACELABS HAS AN OPEN FCA IN PROGRESS. THIS REPORT IS FOR ONE OF THE HOSPITAL'S THREE TRANSMITTERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other