BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASICCARE ELECTRIC BED

    MDR report key: 4088343 · Received July 5, 2014

    Report

    Report Number
    3003463213-2014-00008
    Event Type
    Malfunction
    Date Received
    July 5, 2014
    Date of Event
    August 31, 2011
    Report Date
    June 10, 2014
    Manufacturer
    OPTIMA HEALTHCARE, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT RELAY USED IN BASIC CARE PCBA BECOMES DAMAGED OVER TIME CAUSING THE RELAY'S TRIGGER TO MELT AND TO 'STICK' IN THE ON POSITION. ONCE THE RELAY IS STUCK, THE ACTUATORS WILL MOVE WITHOUT PRESSING THE CONTROLLER. THE RELAY DAMAGE IS CAUSED BY A FEW DIFFERENT REASONS: UNSTABLE INPUT POWER CAN SEND TOO MUCH POWER INTO THE RELAY CAUSING THE RELAY TO HAVE SPARKS AND MELT TRIGGER. QUICK USE OF THE RELAY CAUSES CONSTANT SPARKS, WHICH IS USED TOO MUCH, WILL CAUSE DAMAGE AND HAVE THE TRIGGER MELT. NOTE: UNDER NORMAL USE, SPARKS DO NOT APPEAR. CORRECTIVE ACTION: IMPROVE RELAY STRENGTH ON BASIC CARE PCBA.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE BED EXPERIENCED AN UNINTENTIONAL MOVEMENT OF THE HEAD UP FUNCTION. THE BED WAS IN THE RETIRED CADRE WARD OF (B)(6) HOSPITAL WHEN THE PROBLEM OCCURRED. THE PATIENT WAS NOT INJURED. THE ISSUE HAS BEEN ISOLATED TO THE CONTROL BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393012 BASICCARE ELECTRIC BED AC POWERED ADJUSTABLE HOSPITAL BED FNL OPTIMA HEALTHCARE, INC. 1440A

    Patients

    Seq Age Sex Outcome Treatment
    1