BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSICCARE ELECTRIC BED

    MDR report key: 4088330 · Received July 5, 2014

    Report

    Report Number
    3003463213-2014-00002
    Event Type
    Malfunction
    Date Received
    July 5, 2014
    Date of Event
    March 25, 2013
    Report Date
    June 10, 2014
    Manufacturer
    OPTIMA HEALTHCARE, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED EMAIL FROM (B)(4) ALLEGING THAT THE BED EXPERIENCED AN UNINTENTIONAL MOVEMENT OF THE HEAD UP FUNCTION. (B)(4) STATED THAT THEY FOUND THE ALLEGED PROBLEM TO BE STRUCK HEAD UP SWITCH IN THE FOOT END CONTROL PANEL (B)(4). (B)(4) STATED THAT WHEN THEY UNPLUGGED THE FOOT END CONTROL PANEL CABLE FROM THE CONTROL BOX THIS CORRECTED THE ALLEGED PROBLEM. A REPLACEMENT CONTROL PANEL WAS SENT FOR REPLACEMENT. VISUAL CHECK OF THE RETURNED CONTROL PANEL: OBVIOUS RUST ON THE PRESS BUTTON. POSSIBLE ROOT CAUSE OF THE ISSUE: PRESS BUTTON MOISTEN SOUR OR ALKALI. IT COULD CAUSE EROSION. IF IT LIE IN THE ENVIRONMENT HIGH TEMPERATURE OR HIGH HUMIDITY, IT COULD INCREASE THE SPEED OF RUST OR EROSION RESULT MORE SERIOUS SITUATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE BED EXPERIENCED AN UNINTENTIONAL MOVEMENT OF THE HEAD UP FUNCTION. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392947 BSICCARE ELECTRIC BED AC POWERED ADJUSTABLE HOSPITAL BED FNL OPTIMA HEALTHCARE, INC. 1440

    Patients

    Seq Age Sex Outcome Treatment
    1