BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZU

    MDR report key: 2945686 · Received February 6, 2013

    Report

    Report Number
    0001831750-2013-00794
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ONLY THE MOTOR CONTROLS WERE NOT WORKING ON EITHER SIDERAIL. THIS WOULD RESULT IN ANNOYANCE SINCE MOTOR FUNCTIONS ON THE SIDERAILS WOULD NOT BE AVAILABLE; HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS THE OTHER CONTROLS WERE WORKING INCLUDING NURSE CALL. ADDITIONALLY, MOTOR FUNCTIONS WERE AVAILABLE ON THE FOOTBOARD. 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 BY SERVICE REPORT THAT THE NEITHER SIDE RAIL MOTION CONTROLS WOULD WORK.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE NEITHER SIDE RAIL CONTROLS WOULD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50097 IN TOUCH ZU BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1