BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 97

    MDR report key: 350776 · Received September 7, 2001

    Report

    Report Number
    2221819-2001-00196
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AFTER THE ELDERLY PT WAS TRANSFERRED FROM THE FIRST UNIT, THE CUSTOMER REPORTED THAT WHILE THE SECOND UNIT WAS IN USE ON THE PT, THE UNIT EXPERIENCED DIFFICULTY TRIGGERING WITH A PACEMAKER PACER. THE PT EXPIRED. REFER TO MEDWATCH REPORT NO. 2221819-2001-00195 FOR THE FIRST UNIT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40529 SYSTEM 97 IABP DSP DATASCOPE CORP. SYSTEM 97 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death