BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 2192904 · Received July 25, 2011

    Report

    Report Number
    1219856-2011-00276
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 25, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - HIGH WASTAGE OF HELIUM DURING CLINICAL APPLICATION. FINDINGS/ACTIONS: VALVE NO. 3 IS DEVIANT, ENGINEER SUGGEST FOR REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN