BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2191864 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00135
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP WAS NOT ABLE TO REPRODUCE THE REPORTED PROBLEM. AS A PRECAUTIONARY MEASURE, THE POWER SUPPLY (PART NUMBER (B)(4)) WAS REPLACED. THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT SHUT DOWN WHILE PLUGGED IN. THE CUSTOMER POWER-CYCLED THE UNIT AND IT CAME BACK ON, BUT THEY REPLACED THE UNIT SHORTLY THEREAFTER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK