BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 98

    MDR report key: 311720 · Received January 9, 2001

    Report

    Report Number
    2221819-2001-00002
    Event Type
    Death
    Date Received
    January 9, 2001
    Date of Event
    December 21, 2000
    Report Date
    December 21, 2000
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THIS UNIT WAS IN USE ON A PT, THE UNIT CONSTANTLY GENERATED "LEAK IN IAB CIRCUIT" ALARMS. BLOOD ENTERED THE UNIT. THE PT EXPIRED WHILE ON THIS UNIT. REFER TO MEDWATCH REPORT #2221819-2001-00001 FOR THE FIRST UNIT INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829 SYSTEM 98 IABP DSP DATASCOPE CORP. SYSTEM 98 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death