BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3041520 · Received April 8, 2013

    Report

    Report Number
    0001831750-2013-03020
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE BRAKES WERE DIFFICULT TO ENGAGE/DISENGAGE DUE TO A BRAKE RING WELDMENT THAT HAD BEEN BENT DOWNWARD. THERE WAS REDUCED BRAKE FORCE DUE TO MISSING BRAKE RETAINING RINGS AND BROKEN CASTER BRAKE PIN TUBE GUIDES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE CASTER WERE WORN, WHICH COULD RESULT IN REDUCED BRAKING FORCE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE CASTER WERE WORN, WHICH COULD RESULT IN REDUCED BRAKING FORCE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143051 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1015

    Patients

    Seq Age Sex Outcome Treatment
    1