BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 95

    MDR report key: 240230 · Received September 9, 1999

    Report

    Report Number
    2221819-1999-00332
    Event Type
    Malfunction
    Date Received
    September 9, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 6, 1999
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT SHUTDOWN. THE UNIT WOULD RUN ON D/C POWER, BUT NOT A/C POWER. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 95 IABP DSP DATASCOPE CORP. SYSTEM 95 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN