BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3821288 · Received April 28, 2014

    Report

    Report Number
    1824206-2014-01328
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE SIDE RAIL CENTER ARM ASSEMBLY WAS BROKEN. PER THE HILL-ROM SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE 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 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 SIE RAILS AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2010 AND 2012 TO 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. 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

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN THE BASEMENT OF THE ACCOUNT. THERE WAS NO PATIENT/USER REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254532 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1