BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2760298 · Received September 20, 2012

    Report

    Report Number
    1831750-2012-09980
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 24, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: CUSTOMER EVALUATED UNIT VISUALLY AND FUNCTIONALLY, AND PROVIDED STRYKER SERVICE TECHNICIAN AN IMAGE OF THE ALLEGED DAMAGE. LOAD CELL WELDMENT. REPLACEMENT PART WAS PROVIDED TO CUSTOMER, SUCH THAT THEY REPAIR THE UNIT THEMSELVES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE ZOOM FUNCTION ON THE STRETCHER WAS INTERMITTENT DUE TO A CRACKED LOAD CELL WELDMENT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM304 M-SERIES W/ZOOM POWERED WHEELED STRETCHER FNL STRYKER MEDICAL 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1