BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3973063 · Received June 5, 2014

    Report

    Report Number
    1824206-2014-01721
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE RIGHT SIDE RAIL CTR ARM ASSEMBLY IS BROKEN. THE TECHNICIAN STATED THE CAUSE WAS THE SIDE RAIL WAS RAIN INTO A COLUMN DURING A PT TRANSPORT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2008 THROUGH 2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE RIGHT SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE RIGHT SIDE RAIL IS NOT LATCHING. THE BED WAS LOCATED IN THE BASEMENT AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328625 VERSACARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1