BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2132209 · Received June 6, 2011

    Report

    Report Number
    3003433498-2011-00006
    Event Type
    Other
    Date Received
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER LEANED ON A RAIL WHICH THEN ALLEGEDLY COLLAPSED. BED SYSTEM WAS APPROX 5 YEARS OLD AT TIME OF INCIDENT. MAINTENANCE HISTORY IS UNK. FACILITY FIXED THE BED AND REPLACED THE RAIL FASTENERS. FACILITY DISCARDED PARTS. A MORE THOROUGH ANALYSIS WOULD REQUIRE PRODUCT RETURN. MALFUNCTION HAS NOT BEEN ESTABLISHED. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT INCLUDING ROUTINE MAINTENANCE. MDR FILED BASED ON DR'S VISIT.

    Description of Event or Problem · 1

    THE CONSUMER WAS LEAVING OVER THE BED AND HOLDING ONTO THE RAILS, WHEN THE RAIL ALLEGEDLY GAVE OUT, CAUSING THE CONSUMER TO FALL. THE CONSUMER WENT FOR A CT SCAN AND THERE WERE NO BROKEN BONES. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE ARRO 171 WITH ASSIST RA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention