BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3830217 · Received May 12, 2014

    Report

    Report Number
    1824206-2014-01466
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH FOUND THE COMMUNICATION CABLE NEEDED TO BE REPLACED. PER THE HILL-ROM SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. EXAMINE AND TEST THE COMMUNICATION JUNCTION BOX. MAKE SURE THE SIDECOM COMMUNICATION SYSTEM FEATURE WORKS CORRECTLY. EXAMINE THE COMMUNICATION CABLE; INCLUDE THE MALE AND FEMALE PINS IN THE PLUG. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED FROM 2010 TO 2012. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE NURSE CALL WOULD NOT SEND TO THE NURSES' STATION. THE BED WAS LOCATED IN THE REPAIR AREA AT THE ACCOUNT. 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
    283299 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1