BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE CCU+LIGHT ROW

    MDR report key: 10271461 · Received July 14, 2020

    Report

    Report Number
    1221934-2020-01819
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    January 1, 2018
    Report Date
    June 16, 2020
    Manufacturer
    NO.100 NAN GU ROAD
    Product Code
    FCW
    UDI-DI
    10886705028702
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT THE DEVICE DID NOT DISPLAY THE SCREEN. PER SERVICE MANUAL OPERATIONAL & DIAGNOSTIC AND SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. FOLLOWING DEFECTS WERE IDENTIFIED UPON EVALUATION OF THE COMPLAINT DEVICE: ACCESSORY DEVICE WAS NOT RECOGNIZED, INTERMITTENT OPERATION, NO IMAGE WAS SHOWN ON THE DISPLAY, SYSTEM SOFTWARE WAS DEFECTIVE, MEMORY BACKUP BATTERY WAS DAMAGED, CARRIER BOARD, FPGA BOARD, FRONT BOARD AND QSEVEN MODULE WERE DEFECTIVE, SOCKET, HARD DRIVE AND CONNECTING CABLE WERE DEFECTIVE. ALL THE DEFECTIVE PARTS WERE REPLACED AND THE SOFTWARE WAS RE-INSTALLED TO RESOLVE THE IDENTIFIED FAILURES. WITH THE AVAILABLE INFORMATION, WE CANNOT DETERMINE THE ROOT CAUSE OF THE IDENTIFIED FAILURES. THE FAULTY COMPONENTS OF THE DEVICE AND DEFECTIVE SOFTWARE WOULD HAVE CAUSED THE CUSTOMER TO EXPERIENCE THE REPORTED PROBLEM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER (B)(4), AND THE CERTIFICATE OF CONFORMANCE STATED THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH THE QUALITY SYSTEM RELEASE CRITERIA. SERVICE AND REPAIR FUNCTIONS WERE PERFORMED TO ADDRESS NCR (B)(4). IT WAS CARRIED OUT TO RESOLVE THE DISCREPANCY OF THREE OF THE USB PORTS ON THE BACK OF THE DEVICE NOT DISPLAYING THE KEYBOARD WHEN PLUGGED INTO. BY ADDRESSING NCR (B)(4), IT WAS VERIFIED THAT THE KEYBOARD ICON APPEARS IN THE UPPER-RIGHT CORNER OF THE PURVUE LCD SCREEN WHEN A USB KEYBOARD IS CONNECTED TO EACH OF THE NINE USB PORTS. ALSO, SERVICE AND REPAIR FUNCTIONS WERE PERFORMED TO ADDRESS NCR (B)(4). IT WAS CARRIED OUT TO ENSURE THAT THE LIVE VIDEO APPEARS PROPERLY ON THE NDS SURGICAL DISPLAY WITH THE PURVUE CAMERA HEAD AND LIGHT CABLE CONNECTED. AT THIS POINT IN TIME, NO OTHER CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE ALL IN ONE CCU+LIGHT ROW DEVICE DID NOT DISPLAY THE SCREEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735687 ALL-IN-ONE CCU+LIGHT ROW ENDOSCOPIC VIDEO IMAGING SYSTEM FCW NO.100 NAN GU ROAD 242302 10886705028702

    Patients

    Seq Age Sex Outcome Treatment
    1