BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 145646 · Received January 12, 1998

    Report

    Report Number
    2248146-1998-00040
    Event Type
    Malfunction
    Date Received
    January 12, 1998
    Date of Event
    January 6, 1998
    Report Date
    January 12, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS NOT RETURNED OR RELEASED TO DATASCOPE FOR EVAL. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 5/12/98).

    Description of Event or Problem · 1

    THE DR HAD DIFFICULTIES WEANING THE PT FROM BYPASS AND AN IAB WAS INSERTED. BLOOD WAS NOTED IN THE HELIUM LINE AND THE IAB WAS REMOVED. A SECOND IAB WAS INSERTED INTO THE PT. THE PT WAS ON MULTIPLE DRIPS AND REMAINED IN THE RECOVERY ROOM. THE PT'S CARDIAC INDEX WAS 3.6 AND HAD NUMEROUS INATROPES. (ON 1/12/98, DATASCOPE ALSO REC'D THE MANDATORY MEDWATCH FORM FROM THE DIST; UF/DIST REPORT NUMBER: 2026191-1998-0001). (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00043). THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVAL. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 1/12/98. [PT'S CURRENT STATUS]: IN CCU-RPT'D 1/12/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0307 11/3/99

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR