BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3823684 · Received February 28, 2014

    Report

    Report Number
    9615739-2014-00078
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE BRAKE CASTERS HAD DAMAGED STEMS WHICH ALSO DAMAGED THE BRAKE CASTER SUPPORTS. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. AN INVESTIGATION WAS PERFORMED AND THIS ISSUE WAS ADDRESSED UNDER AN ENGINEERING CHANGE. THE BRAKE CASTER, BRAKE STEER CASTER AND SUPPORTS WERE REPLACED TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE FOOT BRAKE CASTERS ARE NOT HOLDING. THE BED IS LOCATED ON THE GROUND FLOOR HALLWAY AT THE FACILITY. 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
    124030 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1