BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 5

    MDR report key: 7086231 · Received December 6, 2017

    Report

    Report Number
    7086231
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    August 22, 2017
    Report Date
    November 21, 2017
    Manufacturer
    RAULAND
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE INSTALLED THE RAULAND RESPONDER 5 NURSE CALL SYSTEM IN OUR EMERGENCY AND RADIOLOGY DEPARTMENTS ABOUT A YEAR AGO. WE UPGRADED OUR SPACELABS TELEMETRY ANTENNA SYSTEM WHICH INCLUDED REPLACEMENT ANTENNAS AND ADDITIONAL ANTENNAS IN OUR RADIOLOGY DEPARTMENT 4 MONTHS AGO. WHEN WE TURNED ON THE TELEMETRY ANTENNA SYSTEM WE STARTED EXPERIENCING DROPOUT IN SIGNALS FOR SPACELABS CHANNEL 2250 WHICH RUNS ON FREQUENCY 608.2375. THE DROPOUT WAS SIGNIFICANT ENOUGH THAT WE HAD TO DISCONTINUE USING CHANNEL 2250. PER SITE REPORTER: MANUFACTURER RESPONSE FOR TELEMETRY TRANSMITTER/RECEIVER: SPACELABS INVESTIGATED AND FOUND THE RAULAND RESPONDER 5 SYSTEM GENERATES RF AT THEIR DOME LIGHTS THAT FALLS INTO THE SPECTRUM OF THIS TELEMETRY SYSTEM. THE ANTENNAS PICK UP ENOUGH OF THIS RF TO CAUSE THE CHANNEL TO DROP OFF. RAULAND'S RESPONSE HAS BEEN THAT THEY ARE AWARE OF THEIR SYSTEM GENERATING RF AND THEY ARE AWARE THAT THEY CAUSE INTERFERENCE IN OTHER SYSTEMS AND THEIR CURRENT STANCE IS THAT THEY ARE IN COMPLIANCE WITH GUIDELINES. RAULAND INSTALLATION GUIDELINES FOR THE RESPONDER 5 IS OTHER SYSTEMS MUST MAINTAIN A 4 FOOT SEPARATION FROM THEIR EQUIPMENT INCLUDING ANY WIRE/CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867906 RESPONDER 5 NURSE CALL SYSTEM OUG RAULAND RESPONDER V

    Patients

    Seq Age Sex Outcome Treatment
    1