BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 3229703 · Received July 16, 2013

    Report

    Report Number
    0001831750-2013-06368
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE FOWLER COULD NOT LAY FLAT DUE TO THE CPR MECHANISM BEING OUT OF ALIGNMENT AND NOT THE FOWLER CLUTCH AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOWLER COULD NOT LAY FLAT DUE TO THE CPR MECHANISM OUT OF ALIGNMENT. 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 COULD NOT LAY FLAT DUE TO FOWLER CLUTCH MISALIGNMENT. 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
    329237 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1