BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 700114 · Received April 13, 2006

    Report

    Report Number
    1219856-2006-00115
    Event Type
    Injury
    Date Received
    April 13, 2006
    Date of Event
    March 13, 2006
    Report Date
    April 12, 2006
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PRESSURE SIGNAL EVEN THOUGH IAB HAD BEEN CORRECTLY INSERTED. IAB WAS REMOVED, SEROED, AND REINSERTED AND SUBSEQUENTLY, THEY HAD A VERY GOOD AP SIGNAL. PUMP WORKED FOR APPROX. 1 HR W/O PROBLEMS AFTER WHICH CONTINUOUS BELIUM LEAK ALARMS OCCURRED. IAB WAS REMOVED ASSOCIATED PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM DSP ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention