BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE FRENCH

    MDR report key: 5773318 · Received July 6, 2016

    Report

    Report Number
    1219856-2016-00157
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    April 15, 2016
    Report Date
    June 9, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    QN#(B)(4). ADDITIONAL INFORMATION RECEIVED 07/18/2016 THE PUMP WAS ON A PATIENT AT THE TIME OF THE EVENT. PUMP SWITCHED. 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 PUMP WAS STARTUP AS NORMAL. 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 (BATTERY LOAD TEST) UNTIL THE IABP SHUT DOWN (>90MINUTES WITHIN SPEC). A BATTERY LOAD TEST WAS PERFORMED AFTER LETTING THE PUMP CHARGE FOR OVER 8 HOURS AND THE UNIT RAN FOR OVER 90 MINUTES. THE CONDOR POWER SUPPLY PASSED ALL FUNCTIONAL TESTING. VISUAL INSPECTION OF THE CONDOR POWER SUPPLY INTERNAL HARDWARE WAS PERFORMED AND NO COMPONENT DAMAGE OR DEFECT WAS NOTED. SEE OTHER REMARKS SECTION. OTHER REMARKS: 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. CONCLUSION: THE REPORTED COMPLAINT OF "TURNS OFF IN USE" IS NOT CONFIRMED. THE REPORTED PROBLEM COULD NOT BE REPRODUCED DURING THE FUNCTIONAL TEST. THE POWER SUPPLY PASSED FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PUMP TURNS OFF IN USE FINDINGS / ACTIONS TAKEN: POWER SUPPLY REPLACED. PUMP CHECKED AND PASS. SOFTWARE: (B)(4). REASON FOR SERVICE: OTHER REASON UPDATE ON 06/22/2016-PER THE FIELD SERVICE AGENT "THERE WERE NO REPORTS OF COMPLAINTS."

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PUMP TURNS OFF IN USE. FINDINGS / ACTIONS TAKEN: POWER SUPPLY REPLACED. PUMP CHECKED AND PASS. SOFTWARE: 2.24FR. FCN: (B)(4). REASON FOR SERVICE: OTHER REASON. UPDATE ON 06/22/2016-PER THE FIELD SERVICE AGENT "THERE WERE NO REPORTS OF COMPLAINTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427831 AUTOCAT2 WAVE FRENCH INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1