BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3250759 · Received July 29, 2013

    Report

    Report Number
    0001831750-2013-06738
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THAT THE AUXILIARY POWER CORD WAS MISSING GROUND PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD GROUND PIN WAS DAMAGED. IT WAS ALSO REPORTED THAT THE AUXILIARY POWER CORD WAS MISSING GROUND PIN. 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 POWER CORD GROUND PIN WAS DAMAGED. 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
    353285 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1