BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98

    MDR report key: 277132 · Received May 9, 2000

    Report

    Report Number
    2221819-2000-00143
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Report Date
    April 1, 2000
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT AFTER COMPLETING A SOFTWARE UPGRADE FROM REV B TO REV C, THE UNIT WAS SWITCHED OFF AND THEN ON. AFTER "POWERING UP" THE UNIT GENERATED A "SYSTEM FAILURE" ALARM AND "ERROR CODE #5" WAS PRINTED ON THE RECORDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA