BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAULAND RESPONDER-5

    MDR report key: 3483017 · Received November 20, 2013

    Report

    Report Number
    3483017
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    September 16, 2013
    Report Date
    October 28, 2013
    Manufacturer
    CURBELL MEDICAL PRODUCTS, INC.
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS FACILITY HAS HAD MULTIPLE AND REGULAR INSTANCES WERE PATIENTS TRY TO USE THE NURSE CALL SYSTEM AND THE NURSE IS UNABLE TO HEAR THE PATIENT. THE PATIENT ACTIVATES THE CALL LIGHT SYSTEM, BUT THE NURSE IS NOT NOTIFIED. THE STAFF ARE UNABLE TO HEAR THE PATIENT. WE CONTINUE TO SEND THE HAND HELD DEVICE BACK TO THE COMPANY. THE COMPANY REPORTS THAT A SPECIFIC PART WITHIN THE CALL LIGHT IS BREAKING (PART NUMBER 41414U-101393A). THESE ARE PILLOW SPEAKERS, TYPICALLY USED BY PATIENTS WHO DO NOT HAVE USE/CONTROL OF THEIR EXTREMITIES OR WHO ARE NON-VERBAL. THE CALL LIGHT IS ACTIVATED BY THE PATIENT TURNING THEIR HEAD ONTO THE DEVICE. STAFF TEST THE DEVICE WHEN IT IS FIRST INSTALLED IN THE PATIENT ROOM AND THE DEVICE APPEARS TO BE WORKING (THE CALL LIGHT SYSTEM ACTIVATES). HOWEVER, DURING THE COURSE OF CARE, THE CALL LIGHT BREAKS. THERE IS NO WARNING OR SIGNAL THAT THE DEVICE HAS BROKEN. THE CALL LIGHT SYSTEM ITSELF WAS INSTALLED IN 2009.) THERE HAS NOT BEEN PATIENT HARM; HOWEVER, THERE IS INCREASED RISK OF PATIENT HARM BECAUSE THE NURSING STAFF ARE NOT ALERTED TO A PATIENT'S NEED WHEN THE CALL LIGHT SYSTEM IS NOT FUNCTIONING. FACILITIES STAFF ESTIMATE THAT ONE DEVICE OR MORE PER MONTH HAS BEEN RETURNED TO THE MANUFACTURER. THE MANUFACTURER HAS NOT BEEN ABLE TO PROVIDE A REASON FOR THE PROBLEM: THE PART IS REPLACED AND THE DEVICE IS RETURNED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601432 RAULAND RESPONDER-5 SYSTEM, COMMUNICATION ILQ CURBELL MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *