BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCE CUMULA

    MDR report key: 6948130 · Received October 13, 2017

    Report

    Report Number
    6948130
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 19, 2017
    Manufacturer
    HCE (CORNELL LLC.)
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN ACTIVATED, THE NURSE CALL WOULD GIVE AN AUDIBLE SOUND ONLY ONCE AND THE DOME LIGHT OUTSIDE OF THE ROOM WOULD REMAIN LIT. THE AUDIBLE SOUND IS SUPPOSED TO CONTINUE INTERMITTENTLY UNTIL THE CALL IS ANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726840 HCE CUMULA NURSE CALL ILQ HCE (CORNELL LLC.) HWN 7633UA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO