BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSACARE BED

    MDR report key: 3170534 · Received June 5, 2013

    Report

    Report Number
    1824206-2013-02974
    Event Type
    Other
    Date Received
    June 5, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 13, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND TESTED THE BED AND FOUND NO ISSUES WITH THE BED AND THE BED EXIT FUNCTIONED AS DESIGNED. THE ACCOUNT STATED THAT THE PATIENT WAS FOUND ON THE FLOOR AND THE BED EXIT DID NOT ALARM AND THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE PATIENT POSITION MODULE WAS SET BUT DID NOT ALARM. THE ACCOUNT ALLEGED THAT DUE TO THE PATIENT POSITION MODULE NOT ALARMING A PATIENT FALL INCURRED. THE ACCOUNT ALLEGED THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249525 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other