BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2191653 · Received July 1, 2011

    Report

    Report Number
    1831750-2011-06711
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: FAULTY CPU BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS NOT FUNCTIONING CORRECTLY. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3002 SECURE II A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1