BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW/KONTRON 9FR INTRA-AORTIC BALLOON

    MDR report key: 158059 · Received March 20, 1998

    Report

    Report Number
    1219856-1998-00052
    Event Type
    Injury
    Date Received
    March 20, 1998
    Date of Event
    December 12, 1997
    Report Date
    March 18, 1998
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTROL NO. II 980053. THE SAMPLE HAS BEEN RETURNED TO ARROW. EXAMINATION AND TESTING FAILED TO CONFIRM THE CUSTOMER'S COMPLAINT. IN-HOUSE TESTING ON A PUMP FOR APPROX 10 MINUTES, FAILED TO DETECT ANY PROBLEMS. WE WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IAB WAS INSERTED, THE PUMP'S HI PRESSURE ALARMS REGISTERED, AND THE PUMP STARTED PUMPING. THE USER COULD NOT RESOLVE THE PROBLEM, SO THE IAB WAS REMOVED AND REPLACED. THERE WERE NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW/KONTRON 9FR INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP ARROW INTL., INC. NA 030797

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention