BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2091206 · Received April 20, 2011

    Report

    Report Number
    1831750-2011-03833
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: HANDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE ZOOM HANDLES/COVERS WERE BROKEN. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1