BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 4203653 · Received July 22, 2014

    Report

    Report Number
    9615739-2014-00293
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND LEFT STEER, RIGHT BRAKE CASTER, AND BOTH CASTER SUPPORTS INOPERABLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 AND 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED LEFT STEER, RIGHT BRAKE CASTER, AND BOTH CASTER SUPPORTS 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 FOOT END CASTERS NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN THE BED SHOP. 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
    429291 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1