BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2133840 · Received May 12, 2011

    Report

    Report Number
    1831750-2011-04568
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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: SCALE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS NOT FUNCTIONING CORRECTLY AS IT WAS OFF BY ABOUT 10 POUNDS. 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