BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 6291470 · Received January 31, 2017

    Report

    Report Number
    3006697241-2017-00011
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    December 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE POWER CONTROL 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. 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 BAR OR THE LH/RH BRAKE PEDALS ARE PRESSED. REPAIR AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2016. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CONTROL 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 THE ACCOUNT STATING THE BRAKE NOT SET ALARM WAS NOT SOUNDING. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73763 CAREASSIST ES120/220/420 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM MEXICO P1170G0000230

    Patients

    Seq Age Sex Outcome Treatment
    1