BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3950704 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00880
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    December 15, 2013
    Report Date
    December 18, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMP REP VISITED THE FACILITY AND VERIFIED THAT THE IABP DID NOT HAD A MALFUNCTION. IN CONVERSATION WITH THE CLINICAL STAFF WAS DETERMINING THAT THE IABP WAS IN SEMI AUTO OPERATION AND WAS READING A SLAVED SIGNAL. WHEN THE CUSTOMER REMOVED THE SLAVED SIGNAL AND WENT DIRECT THE IABP, WAS NOT CHANGED BACK TO DIRECT BY THE OPERATOR WHICH IS REQUIRED WHEN IT IS IN SEMI AUTO MODE. TRAINING WAS PROVIDED TO THE CLINICAL STAFF REGARDING THE ISSUE. 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. OPERATION MANUAL FOR CS300 (0070-10-0654-01) SECTION 1.4 EXPLAINS HOW TO CHANGE CORRECTLY BACK TO DIRECT IN AUTO MODE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP WAS UNABLE TO OBTAIN PRESSURE TRIGGER. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331678 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR