BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 7444622 · Received April 19, 2018

    Report

    Report Number
    2249723-2018-00662
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 19, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) ALARMED "LEAK IN IAB CIRCUIT" . THE CUSTOMER VERIFIED THAT ALL CONNECTIONS WERE WELL CONNECTED, BUT THE ALARM REAPPEARED AFTER THE DOCTOR RESTARTED THE IABP. THERE WAS NO PATIENT HARM AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286078 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1