BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISA

    MDR report key: 123240 · Received September 26, 1997

    Report

    Report Number
    2221819-1997-00573
    Event Type
    Malfunction
    Date Received
    September 26, 1997
    Date of Event
    June 24, 1997
    Report Date
    June 24, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PREPARING THE UNIT FOR USE ON A PT, THEY PERFORMED A ROUTINE CHECK OF THE UNIT, AND THE EKG INFO WAS NOT DISPLAYED ON THE CENTRAL STATION MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISA CENTRAL STATION MONITOR DRT DATASCOPE CORP. VISA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN