BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2951047 · Received February 8, 2013

    Report

    Report Number
    3003433498-2013-00092
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING A BEND IN THE HEAD DECK. IT WAS DETERMINED THE PATIENT USING THE BED WAS UNDER THE WEIGHT CAPACITY. IT WAS REPORTED THE DECK SECTION WAS REPLACED UNDER WARRANTY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53823 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other