BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 177983 · Received July 16, 1998

    Report

    Report Number
    2248146-1998-00803
    Event Type
    Malfunction
    Date Received
    July 16, 1998
    Date of Event
    June 7, 1998
    Report Date
    July 2, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00851) THE PATIENT TURNED AND THE PUMP STOPPED. "CHECK CATHETER" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 12/17/98: ANOTHER IAB WAS NOT INSERTED INTO THE PATIENT. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 6/8/98. THE PATIENT EXPIRED ON 7/98. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 7/2/98 AND 12/17/98. [PATIENT'S CURRENT STATUS]: EXPIRED - RPT'D 12/17/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHERER DSP DATASCOPE CORP. 0684-00-0283 01/18/00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR