BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 97E

    MDR report key: 351312 · Received September 7, 2001

    Report

    Report Number
    2221819-2001-00180
    Event Type
    Malfunction
    Date Received
    September 7, 2001
    Date of Event
    July 20, 2001
    Report Date
    July 24, 2001
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE PATIENT WAS DISCONNECTED FROM THE HEART-LUNG MACHINE AND CONNECTED TO AN IABP, THE CUSTOMER REPORTED THAT THE UNIT GENERATED A "NO TRIGGER" ALARM, PUMP FOR A FEW BEATS, THEN GENERATED ANOTHER IABP USING DIFFERENT CABLES BUT THE PROBLEM PERSISTED. THE CUSTOMER REPORTED THAT "EVENTUALLY THE PATIENT EXPIRED". REFER TO MEDWATCH REPORT NO. 2221819-2001-00197 FOR SECOND UNIT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40764 SYSTEM 97E IABP DSP DATASCOPE CORP. SYSTEM 97E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR