BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2013778 · Received February 4, 2011

    Report

    Report Number
    1219856-2011-00041
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY HAD HORIZONTAL WHITE LINES AND SCROLLS DOWNWARDS WHILE ON PATIENT. FINDINGS/ACTIONS TAKEN: THE PUMP WAS SWITCHED OUT WITHOUT INCIDENT. THERE WERE NO KNOWN COMPLICATIONS OR INJURY TO THE PATIENT. THE CONTROL HEAD WAS REPLACED. IABP IN WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KR6085398

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK