BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2090841 · Received May 11, 2011

    Report

    Report Number
    1831750-2011-04533
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULT CODE: CASTER TUBE, RETAINER RING. DURING THE EVALUATION, THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE BRAKES WERE ABLE TO BE ENGAGED AND DID NOT COME OUT OF BRAKE UNLESS STEPPING ON THE PEDAL TO RELEASE THEM. A CASTER TUBE WAS FOUND TO BE DAMAGED AND WAS MISSING A RETAINER RING. AS A PRECAUTION, THE SERVICE TECHNICIAN REPLACED THE CAM BRACKET ASSEMBLY, BRAKE CAM, RETAINER RING AND THE DAMAGED CASTER TUBE. SHOULD ADDITIONAL INFORMATION BE OBTAINED ABOUT THIS EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BRAKES WERE NOT HOLDING AND A BROKEN BONE RESULTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ABOUT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1