BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1881853 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00717
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ARROW INTERNATIONAL 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). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: INTRA-AORTIC BALLOON PUMP (IABP) LESS THAN 12 MONTHS OLD. SYMPTOM - ARTERIAL PRESSURE "TRANSDUCER UNABLE TO ZERO" MESSAGE. FINDINGS/ACTIONS TAKEN: OBSERVED "UNABLE TO ZERO MESSAGE" ONCE. UNABLE TO OBSERVE/REPRODUCE MESSAGE AFTER THAT. REPLACED ARTERIAL PRESSURE INTERCONNECT CABLE AND FRONT END BOARD AS A PRECAUTION. IABP PASSED FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC. KC0077448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK