BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3041530 · Received April 8, 2013

    Report

    Report Number
    0001831750-2013-03017
    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
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# WAS ADDED. THIS WAS NOT INCLUDED IN THE PREVIOUSLY ISSUED INITIAL REPORT FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BIG WHEEL WOULD NOT DISENGAGE FROM STEER, 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 BY SERVICE REPORT THAT THE BIG WHEEL WOULD NOT DISENGAGE FROM STEER, 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
    143287 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1025

    Patients

    Seq Age Sex Outcome Treatment
    1