BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 4014180 · Received August 18, 2014

    Report

    Report Number
    0002936485-2014-00604
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K123441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED. THE FOLLOWING REPAIR DIAGNOSTIC CODES WERE IDENTIFIED: SFB BOARD DEFECT. THE FOLLOWING SERVICE CODES WERE IDENTIFIED: REPLACED SFB STAMP. TIER 1 PUMP REPAIR. UPGRADED SOFTWARE. THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION : NO PHYSICAL DAMAGES SEEN ON THE UNIT. FUNCTIONAL INSPECTION : THE PUMP BOOTED UP. THE CRITICAL ERROR LOG WAS ALSO REVIEWED AND THERE WERE NO ERRORS RELATED TO THE COMPLAINT. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED : SCREEN FREEZE TEST - PASSED. POWER CYCLING WITH ACTIVATION - PASSED. MANUAL BURN-IN TEST - PASSED. QIP10202 STEP 80 - INTEGRATION TEST - PASSED. THE CUSTOMERS COMPLAINT WAS NOT DUPLICATED, NO PROBLEM FOUND. HOWEVER, RECOMMEND TO HAVE THE SOFTWARE UPDATED. THIS DOES NOT CONFIRM THE ALLEGED FAILURE MODE OF THE TOUCH SCREEN OF THE CROSSFLOW PUMP DID NOT RESPOND. PROBABLE ROOT CAUSE: PRESSURE SENSOR MALFUNCTION/OUT OF CALIBRATION. INFLOW CASSETTE/ TUBING PRESSURE SENSOR MEMBRANE FAILURE. MIS-INSERTED CASSETTE/ TUBING. MOTOR ENCODER MALFUNCTION/FAILURE. ROLLER WHEEL ASSEMBLY (INFLOW AND/OR OUTFLOW) MALFUNCTION/FAILURE. ROLLER WHEEL FAILURE DUE TO PERISTALTIC TUBING DEBRIS BUILD-UP. MAIN BOARD (ALL) /IMX FAILURE. SOFTWARE MALFUNCTION. USE ERROR. SYSTEM DESIGN. UNWANTED MOVEMENT OF INTERNAL COMPONENTS/WIRING. PRESSURE SENSOR IS OPERATED ABOVE LINEAR PRESSURE READING RANGE. PUMP OPERATED AT LEAST-FAVORABLE ENVIRONMENTAL CONDITIONS FOR EXTENDED PERIOD OF TIME. RUN SCREEN DOES NOT ADEQUATELY INDICATE OVERPRESSURE SITUATION. MINIWASH MALFUNCTION (CF). COMMAND NOT REGISTERED FROM HAND CONTROL (ALL), FOOTSWITCH (CF), SIDNE (FC, AP) OR HERMES (AP-HERMES READY). EXCESSIVE USE OF WASH OR TURBO. SLOW REACTION TIME TO A QUICKLY CLOSED OFF SHAVER OUTFLOW AT HIGH FLOW RATES. POWER FAILURE OF PUMP. PRESSURE SENSOR STUCK BEHIND THE SENSOR BRACKET. IN SUM, THE PRODUCT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN WAS UNRESPONSIVE AND IT WAS UNABLE TO CHANGE THE PRESSURE OR STOP THE PUMP, WHICH CAUSED OVER-INFLATION OF THE SHOULDER. PHOTOS ARE PROVIDED TO SHOW THE ACTUAL SIZE OF THE SHOULDER AND IT WILL TAKE 48 HOURS TO KNOW IF THERE ARE ANY COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN WAS UNRESPONSIVE AND IT WAS UNABLE TO CHANGE THE PRESSURE OR STOP THE PUMP, WHICH CAUSED OVER-INFLATION OF THE SHOULDER. PHOTOS ARE PROVIDED TO SHOW THE ACTUAL SIZE OF THE SHOULDER AND IT WILL TAKE 48 HOURS TO KNOW IF THERE ARE ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492095 CROSSFLOW CONSOLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1