BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3905460 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00813
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    December 7, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 HELIUM TANK GAUGE (READ 1720 PSI), CHECKED THE PNEUMATIC PERFORMANCE SERVICE DIAGNOSTIC, PERFORMED THE FUNCTIONAL TESTS, VERIFIED THAT THE UNIT MET THE FACTORY SPECIFICATIONS, PERFORM ELECTRICAL SAFETY TESTS AND RAN THE IABP FOR OVER TWO (2) HOURS IN THE ASSIST MODE. THE AUTO AUTOFILL CYCLE WAS COMPLETED. IN ADDITION, THE IABP WAS SETUP TO RECORD EVERY ONE HALF (0.5) HOUR. THE IABP WAS FUNCTIONING AND WAS RELEASED TO THE CUSTOMER. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF THE PATIENT BASIC INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED SEVERAL "AUTOFILL" FAILURES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314990 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1