BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2191836 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00159
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE POWER SUPPLY HAS BEEN RETURNED TO DATASCOPE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS USED ON A PT, THE UNIT SHUTDOWN. THE PUMP WAS REPLACED AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK