BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3031375 · Received April 2, 2013

    Report

    Report Number
    0001831750-2013-02810
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE ELECTRICAL BED CONTROLS WERE NOT ALL WORKING FROM THE HEAD RIGHT DUE TO A DAMAGED SIDERAIL CABLE; HOWEVER, THE ELECTRICAL CONTROLS WERE STILL FUNCTIONAL AT THE OPPOSITE SIDERAIL. THIS WOULD RESULT IN ANNOYANCE, BUT IS NOT LIKELY TO HARM THE PATIENT SINCE THE SAME FUNCTIONS ARE STILL AVAILABLE. 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 THAT THE SIDERAIL CONTROLS WERE NOT FUNCTIONING PROPERLY. NO PATIENT WAS AFFECTED AND NO ADVERSE EVENTS OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDERAIL CONTROLS WERE NOT FUNCTIONING PROPERLY. NO PATIENT WAS AFFECTED AND NO ADVERSE EVENTS OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134367 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1