BEUDAMED
    FDA Adverse Event Death Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2104045 · Received May 17, 2011

    Report

    Report Number
    1831750-2011-04764
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR, MODEL AND SERIAL NUMBER WERE NOT PROVIDED. THIS EVENT WAS RELAYED DURING A DISCUSSION ABOUT THE SM204 M-SERIES W/BIG WHEEL. SHOULD FURTHER DETAILS BE OBTAINED RELATED TO THIS EVENT, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRETCHER FLIPPED OVER WHILE A PT WAS ATTEMPTING TO EXIT THE UNIT AND THAT THE PT DIED. THE PT WAS TRYING TO EXIT OVER THE RAISED SIDERAILS AT THE FOOTEND OF THE STRETCHER. IT WAS REPORTED THAT THE PT WEIGHED (B)(6) AND WAS NOT BEHAVING PREDICTABLY AT THE TIME OF THE INCIDENT. IT IS NOT CERTAIN THAT THE EVENT OCCURRED WITH A STRYKER PRODUCT. IT IS NOT KNOWN IF THE DEATH WAS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death