BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 45613 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00054
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 20, 1996
    Report Date
    August 23, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED ON 8/19/96 AT 1335. AT 0010 ON 8/20/96, THERE WAS A SUDDEN BACK-FLOW OF BLOOD INTO THE CATHETER. THE BALLOON HAD LEAKED. THE PT HAD BEEN IN BED WITHOUT ANY SIGNIFICANT MOVEMENT. THE IAB WAS REMOVED BY THE SURGEON AND ANOTHER WAS INSERTED AT 0100. CO WAS INFORMED OF THIS COMPLAINT VIA THE MANDATORY MEDWATCH FORM RECEIVED FROM THE USER FACILITY ON 8/23/96; UF/REPORT #: 1964000-1996-0007).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684000211-01 7/12/98

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR