BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2940004 · Received February 1, 2013

    Report

    Report Number
    1531186-2013-00360
    Date Received
    February 1, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 30, 2013
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER END USER, THE CASTER IS BENT WHERE IT GOES INTO THE BED FRAME. PROVIDER STATED THAT THEY SET UP THIS BARIATRIC BED FOR A PATIENT AND IT WAS FINE. THE PATIENT CALLED BACK THE NEXT DAY TO SAY IT WAS BENT. PROVIDER STATED HE HAS NO IDEA HOW IT COULD HAVE BEEN POSSIBLE FOR THE CASTER TO BEND LIKE THIS. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44281 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL LAND AMERICA HEALTH & FITNESS BARPKGIVC-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other