BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 1230364 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00517
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO HOURS OF PUMPING, THE "LEAK ALARM SOUNDED" AND THE PUMP WAS EXCHANGED OFF THE PATIENT. THE SECOND PUMP DID NOT ALARM "THEREFORE, THE HOSPITAL WANTS THE PUMP SERVICED". THE PUMP IS NOW AT ANOTHER COUNTRY'S CO AND WILL BE SERVICED. A REQUEST HAS BEEN MADE FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK