BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2052037 · Received March 2, 2011

    Report

    Report Number
    1219856-2011-00087
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PUMP WAS ON PT. SYMPTOM - SYSTEM ERROR 6 (4). FRONT END CONTROLLER FAILURE. FINDINGS/ACTION TAKEN: USER STATED SYSTEM ERROR 6, FOUR TIMES, CONTINUOUSLY. RESET AND ERROR AGAIN. COULD NOT REPRODUCE SYMPTOM. THIS HAPPENED ON BACK UP PUMP ALSO. REPLACED FRONT END BOARD (FEB), ECG "NIKOLAY", ECG FEB CABLES. SYSTEM FUNCTIONED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KC0118413

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK