BEUDAMED
    FDA Adverse Event Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2802264 · Received October 23, 2012

    Report

    Report Number
    1531186-2012-01245
    Date Received
    October 23, 2012
    Report Date
    October 22, 2012
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CUSTOMERS CAREGIVER, REPORTEDLY THE BED RAILS HAVE BROKEN ON THE AREA WHERE THEY CONNECT TO THE BED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 IKZ LAND AMERICA HEALTH & FITNESS BED-10IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other