BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES100/200/400

    MDR report key: 6033265 · Received October 17, 2016

    Report

    Report Number
    9615739-2016-00078
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    HILL-ROM FRANCE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT CONTACTED HILL-ROM TECHNICAL SUPPORT TO HAVE A QUOTE SUBMITTED FOR INSURANCE APPROVAL TO REPAIR THE BED. 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 ACCOUNT PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE CUSTOMER STATING THE BRAKES AT THE FOOT END OF THE BED WERE NOT HOLDING. THE BED WAS LOCATED AT THE CUSTOMER'S HOUSE. THERE WAS NO PATIENT/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
    685201 CAREASSIST ES100/200/400 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM FRANCE P1170D0000042

    Patients

    Seq Age Sex Outcome Treatment
    1