BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZU

    MDR report key: 3151600 · Received June 7, 2013

    Report

    Report Number
    0001831750-2013-05168
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS IT WAS DETERMINED THE FOOT END CASTER NOT SWIVELLING DUE TO A BROKEN CASTER STEM WOULD BE AN ANNOYANCE RESULTING IN THE BED BEING HARDER TO MOVE, HOWEVER; IT IS NOT LIKELY TO HARM THE PATIENT AS THE PATIENT COULD STILL BE TRANSPORTED AND THE BRAKES WERE STILL FUNCTIONAL. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE CASTER 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 CASTER WAS BROKEN WHICH MAY HAVE RESULTED IN REDUCED BRAKE FORCE. 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
    253092 IN TOUCH ZU BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1