BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3013608 · Received March 20, 2013

    Report

    Report Number
    0001831750-2013-02252
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS FURTHER INVESTIGATION DETERMINED THAT FOWLER WAS UNABLE TO RISE COMPLETELY AND THE FOWLER ANGLE WAS INACCURATE DUE TO A BROKEN WELD ON THE FOWLER. THIS WILL RESULT IN CAREGIVER ANNOYANCE SINCE FOWLER WAS UNABLE TO RAISE. ADDITIONALLY, IT IS NOT LIKELY TO HARM THE PATIENT AS THAT IS THE DESIRED POSITION FOR CPR ADMINISTRATION IF REQUIRED A CAREGIVER AND FOWLER ANGLE WAS INACCURATE WOULD RESULT IN USER ANNOYANCE AS THE BED ANGLE READING IS USED FOR REFERENCE ONLY AND IT WAS REPORTED THAT NO BED FUNCTIONS WERE AFFECTED. 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 WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MOTION INTERRUPT PAN WAS HANGING DOWN. 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 FOWLER COULD NOT BE LOWER DUE TO BROKEN FOWLER WELDMENT AND ALSO MOTION INTERRUPT PAN WAS HANGING DOWN. 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
    115663 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1