BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2930937 · Received January 28, 2013

    Report

    Report Number
    3003433498-2013-00054
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 26, 2013
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) USER FACILITY HAS REPORTED LOOSE BED RAILS. THE PROVIDER CHANGED THE HARDWARE ON THE ASSIST RAIL WITH LOCK NUTS INSTEAD OF THE BLACK WING NUT. THE DEVICE HAS BEEN IN USE FOR APPROXIMATELY 2 WEEKS. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36671 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE ICHS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other