BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5726898 · Received June 15, 2016

    Report

    Report Number
    1219856-2016-00138
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 6, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALARM BOARD ASSEMBLY (P/N: 77-1110-001, S/N: (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF ALARM BOARD ASSEMBLY AND WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE ALARM BOARD ASSEMBLY IN QUESTION WAS THEN INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE PUMP WAS POWERED UP SUCCESSFULLY AND NO ALARMS. THE PUMP WAS LEFT TO RUN FOR SIX HOURS WITHOUT ANY ALARMS OR ERRORS. THE FUNCTIONALITY OF ALARM BOARD CIRCUITRY WAS PERFORMED BY REMOVED THE AC POWER CORD, SWITCHED OFF THE DC CIRCUIT BREAKER, AND THEN TURNED ON THE MAIN POWER SWITCH. THE SYSTEM WAS ALARMED FOR APPROXIMATELY 30 SECONDS. THE PUMP WITH THE ALARM BOARD ASSEMBLY IN QUESTION FUNCTIONED AS INTENDED. THE ALARM BOARD ASSEMBLY PASSED FUNCTIONAL TESTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. OTHER REMARKS: CONCLUSION: THE REPORTED COMPLAINT OF "ALARM BOARD ALARMING CONSTANTLY IN AC OR DC" IS CONFIRMED BY THE FIELD SERVICE ENGINEER; HOWEVER, THE REPORTED PROBLEM COULD NOT BE REPLICATED AT THE TELEFLEX CHELMSFORD FACILITY DURING THE FUNCTIONAL TEST. THE ALARM BOARD ASSEMBLY PASSED FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: ALARM BOARD ALARMING CONSTANTLY IN AC OR DC POWER. FINDINGS / ACTIONS TAKEN: REPLACED ALARM BOARD - UNIT CHECKS-OK FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24. OP = ON PATIENT, CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4), SYMPTOM: ALARM BOARD ALARMING CONSTANTLY IN AC OR DC POWER; FINDINGS / ACTIONS TAKEN: REPLACED ALARM BOARD - UNIT CHECKS-OK. FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24; OP = ON PATIENT, CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381696 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1