BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES155/255/455, NUL

    MDR report key: 5018054 · Received August 20, 2015

    Report

    Report Number
    9615739-2015-00249
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    HILL-ROM FRANCE
    Product Code
    FNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE COMMUNICATION CABLE MISSING A PIN. 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. SIDECOM® COMMUNICATION SYSTEM: INSPECT AND TEST THE COMMUNICATION JUNCTION BOX. MAKE SURE THE SIDECOM® COMMUNICATION SYSTEM FEATURES OPERATE CORRECTLY. INSPECT THE COMMUNICATION CABLE, INCLUDING THE MALE AND FEMALE PINS IN THE PLUG. REPLACE AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2015. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE 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 NURSE CALL NOT WORKING. THE BED WAS LOCATED 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
    553023 CAREASSIST ES155/255/455, NUL A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM FRANCE 1170

    Patients

    Seq Age Sex Outcome Treatment
    1