BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSACARE BED

    MDR report key: 3878078 · Received June 9, 2014

    Report

    Report Number
    1824206-2014-01732
    Event Type
    Other
    Date Received
    June 9, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND NO ISSUES. THE BED EXIT FUNCTIONED AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. THERE WAS NO EVIDENCE OF A MALFUNCTION. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT DID NOT ALARM AND A PATIENT FELL OUT OF THE BED. THE BED WAS LOCATED IN THE GREEN TOWER ROOM 755. THE NURSING STAFF FOUND THE PATIENT ON THE FLOOR WITH A CUT ON THEIR FOREHEAD THAT REQUIRED 9 STITCHES. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335317 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention