BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3924947 · Received June 24, 2014

    Report

    Report Number
    1824206-2014-01831
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE SIDE RAIL HAD MARKS ON THE BOTTOM WHICH WOULD MOST LIKELY BE CAUSED BY THE SIDE RAIL MAKING CONTACT WITH AN OBJECT WHILE THE BED WAS BEING LOWERED. 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 TECHNICIAN REPLACED THE SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT THE SIDE RAIL CENTER ARM WAS BROKEN AND WOULD NOT LATCH. THE ACCOUNT DISCOVERED THE ISSUE WHILE HOUSEKEEPING WAS CLEANING THE BED, THE BED WAS LOCATED IN THE BED SHOP THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368103 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1