BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4213085 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01145
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    December 28, 2011
    Report Date
    December 28, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP PERFORMED RUNNING TEST BUT WAS UNABLE TO DUPLICATE THE REPORTED EVENT. AS A PRECAUTIONARY MEASURE, THE PRESSURE TRANSDUCER ((B)(4)) WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PATIENT, THE PUMP STOPPED TO WORK AFTER SEVERAL TIMES PUMPING DUE TO "RAPID GAS LOSS" ALARM. THE IABP CONNECTIONS INCLUDING SAFETY DISK AND TO IABP PORT ON THE PUMP WERE INSPECTED AND NO LOOSE CONNECTIONS WERE FOUND. THE CATHETER WAS REPLACED WITH ANOTHER ONE OF THE SAME SIZE, BUT THE ISSUE PERSISTED. THE PATIENT WAS SWITCHED TO ANOTHER UNIT (SYSTEM98) AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455658 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1