BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 2427243 · Received January 5, 2012

    Report

    Report Number
    1219856-2011-00488
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 4, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT WHILE IN THE INTENSIVE CARE UNIT. A COMPETITOR'S ZEON 8 FR SHORT BALLOON WAS INSERTED INTO THE PT IN THE CATH LAB AND CONNECTED TO AN ARROW AUTOCAT2 WAVE RUNNING ON BATTERY POWER FOR TRANSFERRING THE PT. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE THE AC POWER CORD OF THE PUMP WAS PLUGGED INTO AN ACTIVE AC POWER SOURCE. HOWEVER, THE POWER INDICATOR DID NOT LIGHT AND THE OPERATION WAS NOT SWITCHED TO AC OPERATION. AS A RESULT, THE PUMP WAS SWITCHED OUT FOR A COMPETITOR'S ZEON CONSOLE 908 SUCCESSFULLY. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. NO DELAY OR INTERRUPTION IN THERAPY WAS NOTED. THE PT OUTCOME IS FINE. THE PUMP WILL BE CHECKED IN (B)(6).

    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 62 YR ZEON INTRA-AORTIC BALLOON| ZEON INTRA-AORTIC BALLOON PUMP