BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2852135 · Received November 12, 2012

    Report

    Report Number
    1219856-2012-00331
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. FINDINGS/ACTION TAKEN: REPLACED POWER SUPPLY; INITIALLY UPON TROUBLESHOOTING IT WAS THOUGH THAT THERE WAS AN AP TRIGGERING PROBLEM. AFTER TEMPORARILY REPLACING THE FRONT END, CPU (CENTRAL PROCESSING UNIT) AND I/O (INPUT/OUTPUT) BOARD IT WAS LEARNED THAT THE STIMULATOR, WHEN SET TO A LOW RATE WITH ASSIST INTERVALS OF APPROXIMATELY 10-40% IN OPERATOR MODE, WOULD DISTORT THE WAVEFORM AFTER SEVERAL MINUTES RESULTING IN AP TRIGGER LOSS ALARM. PUMP TRIGGERS NORMALLY WITH VALID AP SIGNAL. POWER SUPPLY BEING RETURNED. IT WAS NOTED THAT SOFTWARE LEVEL WAS 2.24.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: SYMPTOM - DURING GROUND TRANSPORT STAFF REPORTED: BATTERY NOT CHARGING; INTERMITTENT AP (ARTERIAL PRESSURE) TRIGGERING LOSS ALARMS. THE PUMP WAS NOT SWITCHED OUT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    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 UNKNOWN INTRA-AORTIC BALLOON