BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROAUTOCAT2

    MDR report key: 6250577 · Received January 13, 2017

    Report

    Report Number
    1219856-2016-00299
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE REPORTED COMPLAINT IS UNABLE TO BE CONFIRMED BY THE FIELD SERVICE ENGINEER. THE "2.5CC BALLOON VOLUME" COULD NOT BE REPRODUCED, THEREFORE THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IABP SERIAL/ LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: L611483. SYMPTOM: CONTROLLER SYSTEM FAILURE. PUMP STAYS AT 2.5CC VOLUME. FINDINGS/ACTION TAKEN: SCREEN WHITE. REPLACED DISPLAY HEAD COULD NOT DUPLICATE ORIGINAL SYMPTOM. CHECKED ALL CABLES AND CONNECTORS. UNIT CHECKS OK. FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24. OP = ON PATIENT. UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: CONTROLLER SYSTEM FAILURE. PUMP STAYS AT 2.5CC VOLUME. FINDINGS/ACTION TAKEN: SCREEN WHITE. REPLACED DISPLAY HEAD COULD NOT DUPLICATE ORIGINAL SYMPTOM. CHECKED ALL CABLES AND CONNECTORS. UNIT CHECKS OK. FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24, OP = ON PATIENT, UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34280 AEROAUTOCAT2 INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1