BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 97E

    MDR report key: 350806 · Received September 7, 2001

    Report

    Report Number
    2221819-2001-00197
    Event Type
    Death
    Date Received
    September 7, 2001
    Date of Event
    July 20, 2001
    Report Date
    July 24, 2001
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHEN THE PT WAS DISCONNECTED FROM THE HEART-LUNG MACHINE AND CONNECTED TO THE FIRST UNIT, THE FIRST UNIT GENERATED A "NO TRIGGER" ALARM, PUMPED FOR A FEW BEATS, THEN GENERATED ANOTHER "NO TRIGGER " ALARM. AFTER SWITCHING THE PT TO THIS UNIT, THE PROBLEM REPEATED ITSELF ("NO TRIGGER" ALARM, UNIT PUMPED FOR A FEW BEATS, THEN ANOTHER "NO TRIGGER" ALARM) EVEN THOUGH DIFFERENT CABLES WERE USED. THE CUSTOMER REPORTED THAT "EVENTUALLY THE PT EXPIRED." REFER TO MEDWATCH REPORT NO. 2221819-2001-00180 FOR THE EVAL OF THE FIRST UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40492 SYSTEM 97E IABP DSP DATASCOPE CORP. SYSTEM 97E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death