BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASICCARE BED

    MDR report key: 2211299 · Received August 5, 2011

    Report

    Report Number
    1824206-2011-04053
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    OPTIMA HEALTHCARE, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO REC'D INDICATES THE BED WAS FULLY UP, HEAD AND KNEE UP WENT UP AUTOMATICALLY AT THE SAME TIME AROUND MIDNIGHT WITH THE BED BEING OCCUPIED BY A PT. THE PT WAS JUST OUT OF SURGERY WITH AN INCISION ON HER ABDOMEN. THE UNINTENTIONAL MOVEMENT INTO THE CHAIR POSITION CAUSED HARM TO THE PT'S INCISION. THE PT WAS FRIGHTENED AND FELT UNCOMFORTABLE, CAUSING HER TO VOMIT. THE NEXT DAY THE PT HAD FOOT DROPSY, BUT THE HOSP DOES NOT BELIEVE THAT THE SYMPTOMS WERE CAUSED BY THE BED. THE CONTROL BOX WAS REPLACED TO REPAIR THE BED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK