BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 97

    MDR report key: 350781 · Received September 7, 2001

    Report

    Report Number
    2221819-2001-00195
    Event Type
    Death
    Date Received
    September 7, 2001
    Date of Event
    August 25, 2001
    Report Date
    August 27, 2001
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON AN ELDERLY PT, THE UNIT EXPERIENCED DIFFICULTY TRIGGERING ON PACER SPIKES. A MAJOR BLOOD BACK EVENT OCCURRED. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. REFER TO MEDWATCH REPORT NO. 2221819-2001-00196 FOR THE SECOND UNIT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40606 SYSTEM 97 IABP DSP DATASCOPE CORP. SYSTEM 97 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO