BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2043155 · Received February 24, 2011

    Report

    Report Number
    1219856-2011-00084
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PUMP WAS ON PT. SYMPTOM - PUMP STOPPED PUMPING WITHOUT ALARM; ECG PRESSURE, ARTERIAL PRESSURE PRESENT. PUMP DID NOT POWER DOWN, IT JUST STOPPED PUMPING. FINDINGS/ACTION TAKEN: COULD NOT REPRODUCE SYMPTOM. FOUND ASSIST PORT OF INPUT/OUTPUT (I/O) BOARD NOT WORKING. REPLACED CENTRAL PROCESSING UNIT (CPU), I/O BOARD, FRONT END BOARD AND FOUND POWER SUPPLY TO BE FAULT. REPLACED POWER SUPPLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN