BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 188687 · Received September 23, 1998

    Report

    Report Number
    2248146-1998-01077
    Event Type
    Malfunction
    Date Received
    September 23, 1998
    Date of Event
    September 15, 1998
    Report Date
    September 15, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01151) DURING REMOVAL, A HOLE WAS NOTED IN THE MEMBRANE. ON 10/26/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THERE WAS NO BLOOD IN THE PNEUMATIC TUBING AND NO "BLOOD DETECTED" MESSAGE WAS NOTED ON THE PUMP SCREEN. AFTER REMOVING THE IAB, THE USER THOUGHT SHE SAW A HOLE IN THE BALLOON MEMBRANE UP NEAR THE TIP. SHE SQUEEZED THE SITE AND BLOOD CAME OUT. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT REMAINED INTUBATED BUT THE HEMODYNAMICALLY STABLE AFTER THE EVENT ON 9/15/98. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 9/15/98 AND 10/26/98. [PATIENT'S CURRENT STATUS]: STABLE - RPT'D 10/26/98.

    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 08/15/00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR