BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACARE FRAME

    MDR report key: 2980944 · Received February 19, 2013

    Report

    Report Number
    1824206-2013-01014
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HILL-ROM FILED INVESTIGATION, THE BED WAS OPERATING CORRECTLY AND THE AIR PRESSURE IN THE MATTRESS WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, A PATIENT IN A CONTINUING CARE FACILITY WAS COMPLAINING OF SITTING ON SOMETHING HARD. THE PATIENT ALLEGEDLY DEVELOPED A MEDAL ISCHIAL TUBEROSITY STAGE 4. THE SKIN BREAKDOWN STARTED IN (B)(6) 2012 AND GRADUALLY WORSENED OVER TIME. THE PATIENT WAS REMOVED FROM THE BED AND ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72190 VERSACARE FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention