BEUDAMED
    FDA Adverse Event Other Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1426300 · Received July 30, 2009

    Report

    Report Number
    1831750-2009-00627
    Event Type
    Other
    Date Received
    July 30, 2009
    Date of Event
    June 29, 2009
    Report Date
    July 1, 2009
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FPO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATIONS MANUAL STATES THE FOLLOWING REGARDING POWER-WASHING THE STRETCHER: "REMOVE THE MATTRESS PRIOR TO WASHING THE UNIT; DO NOT WASH THE MATTRESS WITH THE STRETCHER." THE MATTRESS WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL DUE TO BIOCONTAMINATION. THE SPECIFIC SERIAL NUMBER OF THE STRETCHER INVOLVED IN THE REPORTED INCIDENT COULD NOT BE IDENTIFIED BY THE CUSTOMER, HOWEVER, THE MATTRESS SERIAL NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BODILY FLUIDS FROM A PT SOAKED THROUGH THE MATTRESS OF A STRETCHER. IT WAS REPORTED THE HOSPITAL HOSED DOWN AND CLEANED THE STRETCHER TWICE BEFORE PUTTING BACK INTO SERVICE. IT WAS THEN REPORTED WHEN THE NEXT PT SAT ON THE MATTRESS, BODILY FLUIDS SEEPED THROUGH THE MATTRESS AND ONTO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other