BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3851449 · Received June 5, 2014

    Report

    Report Number
    3003433498-2014-00112
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE BED RAILS ATTACHED TO AN IHARRO CARROLL HEALTHCARE BED IS ROUGH, USER AND NURSES WERE GETTING SCRAPED. BED RAILS HAVE BEEN REPLACED WITH A SMOOTHER BED BAR. NO INJURY OR MEDICAL INTERVENTION ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328715 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE IHARRO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other