BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II MED/SURG BED

    MDR report key: 3230028 · Received July 16, 2013

    Report

    Report Number
    0001831750-2013-06388
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 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

    CONCLUSION: DEVICE TO BE REPLACED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE FOWLER WAS STUCK IN A LOW, FLAT POSITION. THIS WILL RESULT IN CAREGIVER ANNOYANCE; HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS THIS POSITION IS DESIRED 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 VIA REPAIR WORK ORDER THAT THE FOWLER WOULD NOT LAY FLAT DUE TO BENT FRAME AND BRACES. 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 FOWLER WOULD NOT LAY FLAT DUE TO BENT FRAME AND BRACES. 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
    328368 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1