BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE ITALIAN

    MDR report key: 1842077 · Received August 27, 2010

    Report

    Report Number
    1219856-2010-00566
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 26, 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
    IT
    Reporter Occupation
    UNKNOWN

    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 EXPEDITED QUALITY REVIEW REPORT: SYMPTOM: PURGE FAILURE ALARM. PUMP COULD NOT START THERAPY. ANOTHER AVAILABLE PUMP WAS USED. ACTIONS: THE PNEUMATIC CONTROL SWITCH ASSEMBLY WAS REPLACED, ALTHOUGH THERE IS NO EVIDENCE OF ANY FOREIGN MATERIAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK