BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1589614 · Received November 20, 2009

    Report

    Report Number
    1219856-2009-00527
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    November 6, 2009
    Report Date
    November 20, 2009
    Manufacturer
    ARROW INT'L., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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: PUMP ON PATIENT. SYMPTOM - REPORTED FIBEROPTIX SENSOR (FOS) OUT OF RANGE MESSAGE AND INTERMITTENT DRAIN FAILURE. FINDINGS/ACTIONS TAKEN: OBSERVED FOS OUT OF RANGE MESSAGE AND WAS UNABLE TO CALIBRATE WITH FOS TESTER. VERIFIED FAULTY FOS PRINTED CONTROL BOARD (PCB), REPLACED FOS PCB. FOS READING OUT OF SPECIFICATION, DISPLAY SHOWS 110 MMHG WITH 100 MMHG APPLIED. VERIFIED FOS CONNECTOR FAULTY, REPLACED FOS CONNECTOR. RAN UNIT WITH LOAD SIMULATOR 1 HOUR WITH NO DRAIN FAILURE. FOUND UNIT HAD PREVIOUS HISTORY OF DRAIN FAILURE 1 MONTH AGO. REPLACED PNEUMATIC CONTROL SENSOR (PCS) AS PRECAUTION. UNIT PASSED PREVENTATIVE MAINTENANCE AND FUNCTIONAL CHECKOUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK