BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 3821249 · Received April 28, 2014

    Report

    Report Number
    9615739-2014-00175
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HILL-ROM PLUVINGER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE BRAKE BAR SPACER, CASTER SUPPORT AND BRAKE SWITCH WERE BROKEN. 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. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR, AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. CHECK THE BRAKES TO SEE WHETHER THE BED MOVES WHEN THE BRAKE PEDALS ARE PRESSED AND REPAIR IS NECESSARY. A SEARCH OF THE HILL-ROM RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 AND 2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE BRAKE BAR SPACER, CASTER SUPPORT NAD BRAKE SWITCH TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WERE NO HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN THE HCA WAREHOUSE. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254423 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVINGER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1