BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 90T

    MDR report key: 250494 · Received November 9, 1999

    Report

    Report Number
    2221819-1999-00373
    Event Type
    Malfunction
    Date Received
    November 9, 1999
    Date of Event
    September 2, 1999
    Report Date
    September 7, 1999
    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

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT IN TRANSPORT, THE UNIT FAILED TO DISPLAY AN ECG WAVEFORM OR TRIGGER ECG. THERAPY WAS CONTINUED AND THE CUSTOMER USED THE PRESSURE TRIGGER DURING TRANSPORT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 90T IABP DSP DATASCOPE CORP. SYSTEM 90T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN