BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3020048 · Received March 25, 2013

    Report

    Report Number
    0001831750-2013-02477
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT LATCH DUE TO A BROKEN TOP RAIL. SIDE RAIL WAS BROKEN BY DISRUPTIVE PATIENT HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121897 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1