BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORMER

    MDR report key: 4256221 · Received November 17, 2014

    Report

    Report Number
    0002936485-2014-00935
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: ISOLATION TRANSFORMER MALFUNCTIONS. POWER STRIP MALFUNCTIONS. CIRCUIT OVERLOAD. CURRENT INRUSH. USE ERROR. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIDEO CART SHUT OFF, ALLEGEDLY CAUSING 2-3 MINUTES LOSS OF IMAGE WHILE THE EQUIPMENT REBOOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIDEO CART SHUT OFF, ALLEGEDLY CAUSING 2-3 MINUTES LOSS OF IMAGE WHILE THE EQUIPMENT REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742779 STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORMER CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1