BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES110/210/410

    MDR report key: 6080094 · Received November 4, 2016

    Report

    Report Number
    9615739-2016-00082
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    HILL-ROM FRANCE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE SIDERAIL INTERFACE PC BOARD NEEDED TO BE REPLACED. 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. EVERY FIVE YEARS, THE BED EXIT TAPE SWITCHES SHOULD BE REPLACED BY A FACILITY-AUTHORIZED MAINTENANCE PERSONNEL. ENSURE THE BED EXIT SYSTEM WORKS PROPERLY. REPLACE WORN OR DEFECTIVE PARTS AS NEEDED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2014, 2015 AND 2016. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE HILL-ROM TECHNICIAN REPLACED THE SIDERAIL INTERFACE PC BOARD 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 BED EXIT WAS NOT ALARMING. THE BED WAS LOCATED IN ROOM 32 AT THE ACCOUNT. 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
    730863 CAREASSIST ES110/210/410 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM FRANCE P1170D0000005

    Patients

    Seq Age Sex Outcome Treatment
    1