BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2962168 · Received February 14, 2013

    Report

    Report Number
    0001831750-2013-01176
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, IT WAS DETERMINED THAT THE SCALE WERE ALLEGEDLY NOT DISPLAYING SOMETIMES AND DRAINING BATTERIES QUICKLY. A SPECIFIC CAUSE COULD NOT BE DETERMINED, HOWEVER, AS THE FAULTY COMPONENT WAS NOT MADE AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ALLEGED THAT THE SCALES HAD MALFUNCTIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ALLEGED THAT THE SCALES HAD MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64193 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1015

    Patients

    Seq Age Sex Outcome Treatment
    1