BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872033 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00373
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THE ALARM IN THE LOG JOURNAL BUT WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. IN AN UNRELATED REPAIR THE SAFETY DISK WAS REPLACED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WA IN USE ON A PATIENT, THE IABP GENERATED A "LEAK IN IABP CIRCUIT" ALARM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235215 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other