BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 109393 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00749
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Report Date
    June 30, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF BALLOON LEAKS INVOLVING A MULTI- HOSPITAL IAB STUDY. THE INFORMATION WAS REPORTED IN THE 1994 ISSUE OF "PERFUSION"; VOLUME 9: PAGES 87-94. THIS IS A LITERATURE REFERENCE ONLY. EVENT COMPLICATIONS: NONE REPORTED FROM THE EVENT. (PT'S CURRENT STATUS: UNKNOWN.

    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 CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN