BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3842614 · Received February 24, 2014

    Report

    Report Number
    1824206-2014-00580
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE INTERIOR BASEPLATE IS BENT AND THE SIDE RAIL PLASTIC IS BROKEN AT THE UPPER ASSEMBLY CONNECTION POINT ON THE RIGHT INTERMEDIATE SIDE RAIL. PER THE HILL-ROM SERVICE MANUAL, PERFORM ANNUAL PREVENTATIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. MAKE SURE THE HEAD AND INTERMEDIATE SIDE RAILS ARE NOT BENT OR TWISTED. MAKE SURE THE SIDE RAILS LOCK CORRECTLY IN THE HIGH POSITION AND YOU HEAR THE LATCH CLICK. GENTLY PULL ON EACH SIDE RAIL TO MAKE SURE IT LATCHED CORRECTLY. IF THE SIDE RAIL IS DIFFICULT TO LATCH, MAKE SURE THE LATCH COMPONENTS ARE CLEAN AND LOOK FOR OBSTRUCTIONS. RELEASE EACH SIDE RAIL FROM THE UP POSITION, AND LET IT FALL FREELY. THE SIDE RAIL SHOULD LOWER SLOWLY AND SMOOTHLY. REMOVE THE CENTER ARM COVER, AND EXAMINE THE CABLE ROUTING FOR PINCHING, BINDING, OR DAMAGE. MAKE SURE THE LATCH MECHANISM OF EACH SIDE RAIL IS IN GOOD CONDITION. REMOVE THE SIDE RAIL COVER, AND MAKE SURE THE MOUNTING SCREWS ARE FULLY INSTALLED. MAKE SURE ALL FUNCTIONS ON THE CAREGIVER CONTROL WORK CORRECTLY. REPAIR OR REPLACE THE SIDE RAILS AS NECESSARY. THE TECHNICIAN REPLACED THE RIGHT INTERMEDIATE SIDE RAIL AND MOUNTING BRACKET TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE RIGHT INTERMEDIATE SIDE RAIL WILL NOT LATCH. THE BED IS LOCATED IN ROOM 643 AT THE FACILITY. 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
    111707 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1