BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC PUMP

    MDR report key: 3905484 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00775
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE EVALUATED THE UNIT AND WAS ABLE TO DUPLICATE THE EVENT. THE MANIFOLD DRIVE K7 VALVE WAS REPLACED (PART NUMBER 0104-00-0018). THE COMPANY SERVICE REPRESENTATIVE PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE UNIT WAS RELEASED TO THE CUSTOMER. THE DRIVE MANIFOLD WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4) FOR EVALUATION. THE FAILURE ANALYSIS PERFORMED CONSISTED IN INSTALLING THE PART IN A CS100 IN GOOD OPERATIONAL CONDITIONS. THE DRIVE MANIFOLD WAS EXTENSIVELY TESTED AND THE FAILURE COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    DURING THE PREVENTIVE MAINTENANCE OF THE IABP BY THE COMPANY SERVICE REPRESENTATIVE IT WAS NOTICED THE MESSAGES/ALARMS "MAINTENANCE REQUIRED CODE NUMBER 2" AND "AUTOFILL FAILURE." NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314993 CS100 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1