BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3220611 · Received June 24, 2013

    Report

    Report Number
    1824206-2013-03218
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 30, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND THE ACCOUNT STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A FALL AT HOME. THE NURSE STATED THEY WERE OUTSIDE THE PATIENT'S ROOM AT THE HOSPITAL AND HEARD THE PATIENT FALL. THE NURSE ENTERED THE ROOM AND FOUND THE PATIENT HAD FALLEN ON HER LEFT SIDE. THE NURSE ALLEGEDLY CHECKED THE BED EXIT STATUS ON THE BED AND ALLEGED THAT IT WAS STILL SET BUT NOT ALARMING. THE STAFF DID NOT NOTE WHAT BED THE PATIENT WAS IN AT THE TIME OF THE ALLEGED FALL. THE STAFF DID NOT REMOVE THE BED IN QUESTION FROM SERVICE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THERE WAS A PATIENT FALL RESULTING IN AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284901 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other