BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2192793 · Received July 20, 2011

    Report

    Report Number
    1219856-2011-00257
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 19, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PURGE FAILURE WHEN ATTEMPTING TO USE ON PT. FINDINGS/ACTION TAKEN: BIOMED STATED THAT THEY FOUND THE HELIUM ADAPTOR NOT SEATED PROPERLY INTO THE REGULATOR YOKE AND WHEN THE HELIUM WAS TURNED ON, A GAS LEAK COULD BE HEARD. BIOMED WAS UNABLE TO DUPLICATE THE COMPLAINT OF PURGE FAILURE. UPDATED SOFTWARE TO 2.24. FOUND SMALL SOURCE SIDE HELIUM LEAK, TIGHTENED HELIUM TRANSDUCER ON REGULATOR. UNIT PASSED PREVENTATIVE MAINTENANCE. FUNCTIONAL WAS CHECKED. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE SENIOR SERVICE TECHNICIAN; ACCORDING TO BIOMED, THE PUMP ALARMED WHEN THEY ATTEMPTED TO USE IT ON THE PT. THE PUMP WAS NOT USED ON THE PT. PER A PHONE CALL FROM BIOMED, THE SAME DAY, A NEW PUMP WAS USED WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KC6095745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK