BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122450 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01390
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE PRESSURE REGULATOR (PART #: 0103-00-0351). IN AN UNRELATED REPAIR THE 3.9 INCH/99MM TIE CABLE (PART NUMBER: 0125-01-0001) WAS ALSO REPLACED AND A 2500 HRS PREVENTIVE MAINTENANCE KIT WAS INSTALLED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING A SCHEDULE PREVENTIVE MAINTENANCE, THE COMPANY REP OBSERVED THAT THE 8PSI REGULATOR WAS READING HIGH 583MMHG AND COULD NOT BE RE-CALIBRATED. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587496 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1