BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTCAT2 WAVE

    MDR report key: 1011618 · Received March 10, 2008

    Report

    Report Number
    1219856-2008-00120
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS AT THE HOSP WHEN THE INCIDENT OCCURRED. THE PUMP WAS EXCHANGED WITH ANOTHER PUMP THAT THE HOSP HAD. THERE WERE NO REPORTED PT COMPLICATIONS. THE FIELD SVC REPORT STATES THE FOLLOWING: SYMPTOM: UNIT STOPPED PUMPING WHILE ON PT. UNIT STOPPED PUMPING WHEN AC WAS REMOVED, UNIT NEVER SHUT OFF. FINDINGS/ACTIONS TAKEN: THE FIELD SVC REP WAS UNABLE TO DUPLICATE THE CUSTOMER'S COMPLAINT. UPON INITIAL INSPECTION, FOUND NUTS HOLDING KEY PAD TO DISPLAY HEAD OFF. AS A RESULT, THE KEY PAD WAS REATTACHED. FOUND THE MOTOR CABLE ATTACHED TO THE LEFT SIDE PANEL WITH CLAMP. THE CABLE WAS REATTACHED TO THE CHASSIS. ALL BUSHINGS MISSING ON BOTH SIDE PANELS. INSTALLED BUSHING. REPLACED WORN DISPLAY CABLE, REPLACED MISSING AC RETAINING CLAMP. THE UNIT PASSED ARROW FIELD SVC FUNCTIONAL CHECKOUT. RESULTS: EQUIPMENT OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP (BRAND UNK)