BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 1932766 · Received November 30, 2010

    Report

    Report Number
    1831750-2010-04290
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    INK
    PMA / PMN Number
    K022309
    Removal / Correction Number
    Z-230-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES CONTINUE TO POP OUT OF GEAR. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK