BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1915503 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00790
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    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 - RECEIVED CALL ABOUT PUMP DOUBLE TRIGGERING FROM (B)(6) 2010. NO RECORDER STRIPS AVAILABLE. BIOMED RAN THE PUMP FOR 2 DAYS USING DIFFERENT TRIGGERS AND SOURCES. THEY COULD NOT DUPLICATE THE SYSTEM. FINDINGS/ACTIONS TAKEN: USER WOULD NOT EXCEPT BACK FROM BIOMED UNTIL IT WAS "REPAIRED". BIOMED REPLACED THE FRONT END BOARD. THE PUMP WAS RETURNED TO SERVICE.

    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