BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC

    MDR report key: 191541 · Received October 10, 1998

    Report

    Report Number
    2248146-1998-01130
    Event Type
    Malfunction
    Date Received
    October 10, 1998
    Date of Event
    September 28, 1998
    Report Date
    September 28, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01210) THE 8 FR. IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/16/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS NOTED IN THE TUBING. THE BALLOON WAS STOPPED AND CLAMPED. THE IAB WAS REMOVED AND ANOTHER WAS NOT INSERTED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THE PATIENT'S CARDIAC INPUT HAD IMPROVED. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/28/98; NONE - RPT'D 10/16/98. [PATIENT'S CURRENT STATUS]: IMPROVED-RPT'D 10/16/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0884-00-0009 10/01/00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR