BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 3812564 · Received April 17, 2014

    Report

    Report Number
    9615739-2014-00159
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE CASTERS NEEDED TO BE REPLACED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 AND 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED ALL FOUR CASTERS AND CASTER SUPPORTS ALONG WITH THE MAIN BEARING 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 BRAKES ARE NOT HOLDING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORTED WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236001 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1