BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2210215 · Received July 11, 2011

    Report

    Report Number
    1831750-2011-06899
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ZOOM HANDLE LOAD CELL WELDMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM SYSTEM IS STUDDERING; NOT WORKING CORRECTLY. THE ZOOM DRIVE IS INTERMITTENT. THE CUSTOMER DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1