BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 109375 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00752
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Date of Event
    April 15, 1980
    Report Date
    June 30, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF AN IAB BALLOON EVENT WHERE THE IAB LEAKED. THE INFORMATION WAS REPORTED IN THE 1981 ISSUE OF "INTENSIVE CARE MEDICINE"; VOLUME7; PAGES 311-312. THIS IS A LITERATURE REFERENCE ONLY. (THE BALLOON LEAK WAS EVALUATED AS A PLAQUE RELATED LEAK) (ATTACHED IS A COPY OF THE LITERATURE REFERENCE) (EVENT COMPLICATIONS: UNKNOWN. (PT'S CURRENT STATUS: EXPIRED ON 4/16/80.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR