BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II MED/SURG BED

    MDR report key: 3202443 · Received July 2, 2013

    Report

    Report Number
    0001831750-2013-05993
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE FOWLER WAS STUCK IN THE FLAT POSITION. THIS WILL RESULT IN CAREGIVER ANNOYANCE; HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS THE FOWLER WAS STUCK IN THE DESIRED POSITION 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 REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOWLER HYDRAULIC CYLINDER WAS MALFUNCTIONING. 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 FOWLER MAY HAVE BEEN STUCK IN AN ELEVATED POSITON AS THE FOWLER HYDRAULIC CYLINDER WAS MALFUNCTIONING. 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
    301154 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1