BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEMETRY TRANSMITTER ULTRAVIEW, NB, 1400MHZ

    MDR report key: 1162273 · Received September 5, 2008

    Report

    Report Number
    3023361-2008-00052
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO (B) (6) HOSPITAL'S COMPLAINT, SPACELABS HAD INITIATED A CORRECTIVE ACTION AND SOFTWARE UPGRADE TO ADDRESS REPORTED CHANNEL SWITCHING INCIDENTS. (B) (6) HOSPITAL'S (B) (4) PRODUCTS HAD NOT YET BEEN UPGRADED AT THE TIME OF THIS REPORTED INCIDENT. THE PRODUCTS WILL SHORTLY BE UPGRADED IN THE CORRECTIVE ACTION PROCESS.

    Description of Event or Problem · 1

    (B) (6) HOSPITAL REPORTED THAT A (B) (4) TELEMETRY TRANSMITTER SET TO TRANSMIT ON FREQUENCY CHANNEL 1535 BEGAN TRANSMITTING ON FREQUENCY CHANNEL 1533 INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMETRY TRANSMITTER ULTRAVIEW, NB, 1400MHZ NONE DSI SPACELABS HEALTHCARE 91341-09

    Patients

    Seq Age Sex Outcome Treatment
    1 Other