BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3881452 · Received February 18, 2014

    Report

    Report Number
    9615739-2014-00059
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CASTERS HAD DAMAGED STEMS WHICH ALSO DAMAGED THE CASTER SUPPORTS. AN INVESTIGATION WAS PERFORMED AND THIS ISSUE WAS ADDRESSED UNDER AN ENGINEERING CHANGE. THE TECHNICIAN REPLACED THE FOOT END BRAKE CASTERS AND SUPPORTS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE BRAKES WILL SET ON THE FOOT END OF THE BED BUT ARE NOT HOLDING. THE BED IS LOCATED IN THE BASEMENT OF THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101257 CAREASSIST BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1