BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 6933853 · Received October 10, 2017

    Report

    Report Number
    3006697241-2017-00098
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE LEFT AND RIGHT CAREGIVER CONTROLS 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. INSPECT THE CABLE ROUTING FOR PINCHING, BINDING, AND DAMAGE. MAKE SURE ALL FUNCTIONS ON THE CAREGIVER CONTROL OPERATE CORRECTLY. 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 FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE HILL-ROM TECHNICIAN REPLACED THE LEFT AND RIGHT CAREGIVER CONTROLS 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 FOOT OF BED MOVES ON IT'S OWN. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO SERIOUS INJURY REPORTED TO THE PATIENT/USER. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718682 CAREASSIST ES120/220/420 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM MEXICO P1170G0000276

    Patients

    Seq Age Sex Outcome Treatment
    1