BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 8032782 · Received November 2, 2018

    Report

    Report Number
    3006697241-2018-00090
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE RIGHT CAREGIVER BUTTON 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. MAKE SURE THE HEAD AND FOOT SIDE RAILS ARE NOT BENT OR TWISTED. MAKE SURE THE LATCH MECHANISM OPERATES CORRECTLY. AN AUDIBLE CLICK MUST BE HEARD. REMOVE THE SIDE RAIL COVER, AND MAKE SURE THE MOUNTING SCREWS ARE TIGHT. INSPECT THE CABLE ROUTING FOR PINCHING, BINDING, AND DAMAGE. MAKE SURE ALL FUNCTIONS ON THE CAREGIVER CONTROL OPERATE CORRECTLY. REPAIR OR REPLACE THE SIDE RAIL AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2018. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE RIGHT CAREGIVER BUTTON 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 HILL-ROM TECHNICIAN STATING THE HEAD SECTION WOULD SELF RUN UP. 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
    873264 CAREASSIST ES120/220/420 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM MEXICO P1170G0000293

    Patients

    Seq Age Sex Outcome Treatment
    1