BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2984144 · Received February 28, 2013

    Report

    Report Number
    0001831750-2013-01597
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE BRAKES WERE NOT HOLDING PROPERLY DUE TO THE SCORPION BRAKE PLATE BEING WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING CORRECTLY. 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 BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING CORRECTLY DUE TO WORN SCORPION . BRAKE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88240 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1