BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3001806 · Received March 13, 2013

    Report

    Report Number
    1531186-2013-01047
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SPRINGS ARE COMING OUT OF THE MATTRESS WHICH MAY INJURE A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104900 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL LAND AMERICA HEALTH & FITNESS BED36-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other