BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II MED/SURG BED

    MDR report key: 3173607 · Received June 17, 2013

    Report

    Report Number
    0001831750-2013-05496
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE FOOT END LIFT MOTOR WAS STUCK AT A LOW HEIGHT DUE TO A DAMAGED LIFT MOTOR AND THERE WAS NO SCALE MALFUNCTION AS PREVIOUSLY REPORTED AS A POTENTIAL ISSUE. THE FOOT LIFT BEING STUCK IN THE LOWEST POSITION IS NOT LIKELY TO HARM THE PATIENT AS THE LOWEST FLAT POSITION IS OPTIMAL FOR CPR ADMINISTRATION IF REQUIRED. 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 FOUND THAT THE FOOT END LIFT MOTOR WAS STUCK AT A LOW HEIGHT DUE TO A DAMAGED LIFT MOTOR. 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 THAT THE SCALE MAY HAVE BEEN INACCURATE. 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
    273967 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1