BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 1902501 · Received November 12, 2010

    Report

    Report Number
    1831750-2010-03710
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL BY A STRYKER FIELD SERVICE TECHNICIAN INDICATES THE STRETCHER HAS TAKEN A SIGNIFICANT IMPACT WHICH CAUSED THE REPORTED DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM MOTOR IS JAMMED AND WILL NOT OPERATE, THE GATCH IS LEAKING FLUID, THE FOOT-END JACK IS LEAKING FLUID, THE I.V POLE AND O2 BOTTLE HOLDER BRACKETS ARE BENT, THE GATCH PLASTIC HANDLE IS BROKEN, THE BOLT FOR THE ZOOM "U" BRACKET IS BROKEN, THE FOOT RIGHT UPRIGHT IS BROKEN, AND THE BIG WHEEL WILL NOT RETRACT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA