BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3925079 · Received June 17, 2014

    Report

    Report Number
    1824206-2014-01788
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HILL-ROM INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED EXIT ALARM NOT WORKING DUE TO THE SCALE POWER CONTROL BOARD SPEAKER INOPERABLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2011-2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SCALE POWER CONTROL BOARD SPEAKER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT THAT A HILL-ROM TECHNICIAN FOUND A NOTE ON THE BED STATING THE BED EXIT ALARM IS NOT WORKING. THE BED WAS LOCATED AT THE ACCOUNT IN STORAGE. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355944 VERSACARE BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC 3200

    Patients

    Seq Age Sex Outcome Treatment
    1