BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL ALERT / INTEGO

    MDR report key: 6489484 · Received April 13, 2017

    Report

    Report Number
    6489484
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 20, 2017
    Report Date
    April 10, 2017
    Manufacturer
    CRITICAL ALERT INC. (FORMERLY WESCOM)
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR FACILITY HAS CRITICAL ALERT/INTEGO NURSE CALL THROUGHOUT THE HOSPITAL. MUCH OF THE EQUIPMENT WAS INSTALLED OVER FOUR YEARS AGO. PATIENT STATIONS FAIL FROM TIME TO TIME AND ARE REPLACED WITH NEW ONES ORDERED FROM THE COMPANY. A COUPLE OF MONTHS BACK WE HAD SOME ISSUES WITH THE PATIENT BED WALL BACKLIGHTING. IT WOULD COME ON AND TURN OFF INTERMITTENTLY THROUGHOUT THE DAY AND NIGHT. AFTER EXTENSIVE TROUBLESHOOTING AND RESEARCH WE FOUND THAT CRITICAL ALERT MADE A CHANGE TO THE ELECTRICAL DESIGN OF THE PATIENT STATION REMOVING AN INTERNAL GROUND IN FAVOR OF AN EXTERNAL GROUND TYING A COMMON GROUND TO THE NURSE CALL PATIENT STATION. THIS CHANGE WAS NOT COMMUNICATED WITH THE FIELD AND AS A RESULT IT CAUSED MANY PATIENTS UNDUE STRESS AND MANY LOST MAN HOURS TRACKING DOWN THE PARTICULAR CAUSE. THERE WAS ONE INSTANCE WHERE THE PATIENT HAD A HISTORY OF EPILEPSY AND THE LIGHTING PORTION OF THE SYSTEM HAD TO BE COMPLETELY DISABLED. NO KNOWN PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272650 CRITICAL ALERT / INTEGO SYSTEM, COMMUNICATION, POWERED ILQ CRITICAL ALERT INC. (FORMERLY WESCOM) 5430

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.