BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5950814 · Received September 14, 2016

    Report

    Report Number
    1219856-2016-00207
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 16, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE CONDOR POWER SUPPLY (P/N: 77-0063-001 S/N: (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF CONDOR POWER SUPPLY WAS PERFORMED AND FOUND NO OBVIOUS DAMAGE OR DEFECTS. THE CONDOR POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND FUNCTIONAL TESTING WAS PERFORMED. THE AC WAS NOT PRESENT AND NO LIGHT INDICATORS WERE NOT LID UP WHEN THE PUMP WAS TURNED ON. THE PUMP WAS ALSO ALARMED "SYSTEM RUNNING ON BATTERY POWER". A POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AUTOCAT2 SERIES SERVICE MANUAL (REV 3) AND ALL VOLTAGES WERE WITHIN SPECIFICATION. THE PUMP WAS RUN ON BATTERY UNTIL IT SHUT DOWN. THEN LET THE PUMP CHARGE FOR OVER 9 HOURS. THE PUMP THEN FAILED TO TURN ON. THE CONDOR POWER SUPPLY FAILED ALL FUNCTIONAL TESTING. A POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AUTOCAT2 SERIES SERVICE MANUAL (REV 3) AND FAILED VOLTAGES CHECK. ALL OUTPUT VOLTAGES WERE MEASURED AT 0 VOLT. SEE OTHER REMARKS SECTION. OTHER REMARKS: VISUAL INSPECTION OF THE CONDOR POWER SUPPLY INTERNAL HARDWARE WAS PERFORMED AND NO COMPONENT DAMAGE OR DEFECTS WERE NOTED. THIS IS CONDOR POWER SUPPLY WAS REPLACED ON JANUARY 4TH, 2005. CONCLUSION: THE REPORTED COMPLAINT OF "NO POWER FROM POWER SUPPLY" IS CONFIRMED. THE REPORTED PROBLEM WAS REPRODUCED DURING THE FUNCTIONAL TEST. THE POWER SUPPLY FAILED FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED POWER SUPPLY MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: NO POWER FROM POWER SUPPLY. USER RAN PUMP BUT WAS ON BATTERY POWER UNTIL SHUT OFF. PUMP SWAPPED QUICKLY AND DID NOT HARM PATIENT. FINDINGS/ACTION TAKEN: FOUND, WHILE PLUGGED IN, INDICTOR LIGHTS NOT ON, NO FANS RUNNING, AND NO CHARGING VOLTAGE. CHECKED FUSE, ALL CONNECTIONS, AC INPUT MODULE, ALL DID NOT FIX PROBLEM. REPLACED POWER SUPPLY. FOUND BATTERY WAS AT 12.37V, NEW CHARGING NORMALLY AT 13.34V. PERFORMED FUNCTIONAL CHECKLIST. IABP PERFORM TO SPEC. FCN LEVEL: 16, 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: NO POWER FROM POWER SUPPLY. USER RAN PUMP BUT WAS ON BATTERY POWER UNTIL SHUT OFF. PUMP SWAPPED QUICKLY AND DID NOT HARM PATIENT. FINDINGS/ACTION TAKEN: FOUND, WHILE PLUGGED IN, INDICTOR LIGHTS NOT ON, NO FANS RUNNING, AND NO CHARGING VOLTAGE. CHECKED FUSE, ALL CONNECTIONS, AC INPUT MODULE, ALL DID NOT FIX PROBLEM. REPLACED POWER SUPPLY. FOUND BATTERY WAS AT 12.37V, NEW CHARGING NORMALLY AT 13.34V. PERFORMED FUNCTIONAL CHECKLIST. IABP PERFORM TO SPEC. FCN LEVEL: 16, SOFTWARE LEVEL: 2.24. OP = ON PATIENT, CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600378 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001102349

    Patients

    Seq Age Sex Outcome Treatment
    1