BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 182375 · Received August 11, 1998

    Report

    Report Number
    2248146-1998-00896
    Event Type
    Malfunction
    Date Received
    August 11, 1998
    Date of Event
    May 1, 1998
    Manufacturer
    *
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00947) ON 7/31/98, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER-FACILITY; UF/DIST REPORT NUMBER 490015000-1998-0002 AND THE FOLLOWING INFORMATION WAS REPORTED: THE INTRA-AORTIC BALLOON CATHETER FAILED TO PUMP PROPERLY. THE INTRA-AORTIC BALLOON FAILED TO INFLATE/DEFLATE PROPERLY. ON 11/9/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE "RAPID GAS LOSS ALARM" SOUNDED FROM THE SYSTEM 90 IABP. NO BLOOD WAS SEEN IN THE TUBING. THE CATHETER WAS REMOVED AND ANOTHER WAS INSERTED BECAUSE THE PATIENT WAS VERY IAB DEPENDENT. THE PATIENT'S HEART RATE WAS ELEVATED. THE PATIENT EXPIRED A FEW WEEKS LATER AT ANOTHER HOSPITAL. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 7/31/98 AND 11/9/98. [PATIENT'S CURRENT STATUS]: EXPIRED-RPT'D 11/9/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB * DSP * 0684-00-0283 05/08/99

    Patients

    Seq Age Sex Outcome Treatment
    1 *