BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1188 HD CCU

    MDR report key: 2070380 · Received April 18, 2011

    Report

    Report Number
    2936485-2011-00240
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE WAS CONFIRMED. THE PRODUCT WAS SUBJECTED TO FUNCTIONAL TESTING. A DEFECTIVE INTEGRATED CIRCUIT WAS DISCOVERED ON THE MAIN CIRCUIT BOARD. THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO THIS DEFECTIVE COMPONENT. IN SUM, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT SHUTS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1188 HD CCU CAMERA FXM STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK