BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1002581 · Received February 8, 2008

    Report

    Report Number
    1219856-2008-00031
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    EVENT WAS REPORTED BY FIELD SERVICE REPORT WHICH STATES THE FOLLOWING: LOSS OF TRIGGERS MOMENTARILY. ACTION TAKEN: PERFORMED FULL FUNCTIONAL CHECKLIST, CHECKED SIGNALS FROM PT. ALSO CHECKED SIMULATOR WITH "HOSP" ECG CABLES AND PHONE SLAVE CABLES AS WELL. THE INTRA-AORTIC BALLOON PUMP FUNCTIONED PROPERLY. COULD NOT DUPLICATE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK