BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3151808 · Received June 7, 2013

    Report

    Report Number
    0001831750-2013-05167
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS IT WAS INITIALLY REPORTED THAT THE BED WOULD RAISE BUT NOT LOWER DUE TO CPU BOARD MALFUNCTION; HOWEVER, FURTHER INVESTIGATION DETERMINED THE FOWLER WAS STUCK IN AN ELEVATED POSITION DUE TO THE MALFUNCTIONING CPU BOARD BUT THE MANUAL CPR RELEASE WAS STILL FUNCTIONAL. THIS IS NOT LIKELY TO HARM THE PATIENT AS THE FOWLER COULD STILL REACH ITS LOWEST HORIZONTAL POSITION BY USING THE CPR RELEASE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MOTION INTERRUPT PAN WAS BROKEN. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MOTION INTERRUPT PAN WAS BROKEN. IT WAS ALSO REPORTED THAT THE BED WOULD RAISE BUT NOT LOWER DUE TO CPU BOARD MALFUNCTION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253217 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1