BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 2213832 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02817
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED BY THE CUSTOMER WAS NOT DUPLICATED. REPAIRS WERE DONE ON THE DEVICE AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS WORKING WHEN NOT ACTIVATED. NO FURTHER INFO WAS PROVIDED SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK