BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2982398 · Received February 28, 2013

    Report

    Report Number
    0001831750-2013-01583
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEAD END LIFT WAS STUCK IN AN ELEVATED POSITION DUE TO LOOSE LIFT HOUSING COVER BOLTS. THE LOOSE BOLTS ALLOWED THE LIFT GEAR HOUSING COVER TO MOVE OUT OF POSITION OF THE LIFT POTENTIOMETER, THUS DEPRIVING THE POTENTIOMETER COMMUNICATION TO THE CPU. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86762 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1