BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1063680 · Received June 20, 2008

    Report

    Report Number
    1219856-2008-00298
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 20, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS/ACTION TAKEN: PUMP PASSED ARROW FIELD SERVICE FUNCTIONAL CHECKOUT USING CUSTOMER'S CABLES. PUMP WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT, THAT WHILE ON THE PT THE PUMP STOPPED PUMPING. PUMP SHOWED NO ECG OR ARTERIAL PRESSURE (AP) SIGNAL ON THE DISPLAY. THE CUSTOMER WAS UNABLE TO ATTAIN A TRIGGER USING HIGH LEVEL OR LOW LEVEL ECG OR AP INPUTS. AS A RESULT, THE PUMP WAS SHUT DOWN AND THEN TURNED BACK ON, AT WHICH TIME IT WORKED NORMALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK