BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4241304 · Received September 4, 2014

    Report

    Report Number
    2249723-2014-00570
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE CONFIRMED THE COMPLAINT OF 'AUTOFILL FAILURE' AND 'SAFETY DISK LEAK TEST' ALARMS IN THE FAULT LOG. THE IABP WAS TESTED FOR THE SAFETY DISK LEAK TEST SEVERAL CONSECUTIVE TIMES BUT THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE EVENT. FULL FUNCTIONAL AND ELECTRICAL SAFETY TESTS WERE PERFORMED ON THE IABP UNIT. THE IABP MET THE FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK, IABP GENERATED "AUTO FILL FAILURE" ALARM AND THE IABP FAILED THE SAFETY DISK LEAK TEST. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542952 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1