BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 2050856 · Received April 4, 2011

    Report

    Report Number
    1831750-2011-03237
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: IV POLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE LEFT AND RIGHT UPRIGHT LOCKING SPINDLES WERE BROKEN, THE LEFT TOP RAIL WAS BROKEN WITH EXPOSED SHARP EDGES, AND THE IV POLE WAS BROKEN. TOP RAILS NOT LOCKING INTO PLACE. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 M-SERIES W/5TH WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA