BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE

    MDR report key: 2241171 · Received August 17, 2011

    Report

    Report Number
    1219856-2011-00296
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 16, 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). F/U REPORT WILL BE FILED IF ADD¿L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM; HELIUM LOSS ALARM, SCREEN CHANGING COLORS, PUMP STOPPED PUMPING, ECG AND AP (ARTERIAL PRESSURE) SIGNAL LOSS. NO HARM TO PT. FINDINGS/ACTION TAKEN: WAS UNABLE TO DUPLICATE HELIUM LOSS ALARM, DISPLAY TURNING WHITE AND BLUE AND LOSS OF ECG SIGNAL. WAS ABLE TO DUPLICATE LOSS OF LOW LEVEL AP SIGNAL BY SHAKING AP CABLE; FOUND CONNECTION VERY LOOSE. REPLACED LOW LEVEL AP CABLE CONNECTION, NOW SECURE AND SIGNAL CONSTANT. WAS TOLD BY PARAMEDIC THAT DISPLAY CONNECTION WAS COMING LOOSE BECAUSE OF DISPLAY CONNECTION PUSHED IN AND HAD TO BE PULLED OUT. REPLACED DISPLAY HEAD AS A PRECAUTION, CONNECTION VERY SECURE. INSTALLED FRONT HANDLE. UNIT PASSED FUNCTIONAL CHECKOUT. ADD'L INFO RECEIVED ON (B)(6) 2011 FROM MED FLIGHT STATED THAT THE PUMP IS BACK IN SERVICE. THE ISSUE WAS RESOLVED BY SWITCHING PUMP BACK WITH THE PUMP FROM THE HOSPITAL. THE PT OUTCOME WAS PT OKAY WITH NO COMPLICATIONS FROM THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK