BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3883225 · Received February 20, 2014

    Report

    Report Number
    9615739-2014-00067
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 BRAKE CASTERS, BRAKE STEER CASTERS AND SUPPORTS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCCOUNT REPORTED THAT THE BRAKE CASTERS WILL SET BUT THEY WILL NOT HOLD. THE BED IS LOCATED IN STORAGE AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108413 CAREASSIST BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1