BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 6238977 · Received January 10, 2017

    Report

    Report Number
    9615739-2017-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    HILL-ROM FRANCE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BRAKE CASTER SUPPORTS WERE BROKEN. PER THE HILL-ROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. CHECK THE BRAKES TO SEE WHETHER THE BED MOVES WHEN THE BRAKE PEDALS ARE PRESSED AND REPAIR AS NECESSARY. 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 ACCOUNT REPLACED THE CASTERS 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 THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO SERIOUS INJURY REPORTED TO THE PATIENT/USER. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21937 CAREASSIST ES120/220/420 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM FRANCE P1170D0000049

    Patients

    Seq Age Sex Outcome Treatment
    1