BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122453 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01387
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THE UNIT WOULD POWER UP AND THEN SHUT DOWN. THE COMPANY REP IDENTIFIED THE FAILURE TO DRIVE MANIFOLD ASSEMBLY. THE COMPANY REP REPLACED THE DRIVE MANIFOLD ASSEMBLY (PART# 0104-00-0018). 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 ROUTINE CHECK OF THE IABP, CUSTOMER OBSERVED THAT THE IABP DISPLAY GOES ON THEN OFF INTERMITTENTLY. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587497 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1