BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 90T

    MDR report key: 351327 · Received September 7, 2001

    Report

    Report Number
    2221819-2001-00178
    Event Type
    Malfunction
    Date Received
    September 7, 2001
    Date of Event
    July 26, 2001
    Report Date
    July 26, 2001
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE, THE COMPANY REPRESENTATIVE OBSERVED THAT AFTER A SHORT PERIOD OF TIME, THE BLOOD PRESSURE READINGS AND WAVEFORM WOULD DISAPPEAR FROM THE UNIT'S DISPLAY AND XXX WOULD BE DISPLAYED FOR SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40769 SYSTEM 90T IABP DSP DATASCOPE CORP. SYSTEM 90T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA