BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4093196 · Received August 21, 2014

    Report

    Report Number
    2249723-2014-01241
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    September 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE EVENT OF THE DIRECT ECG SIGNAL NOT SHOWING ON THE SCREEN AFTER PLUGGED INTO THE DIRECT ECG CONNECTOR. AS PER THE COMPANY REPRESENTATIVE, VERIFIED THE ECG CABLE ASSEMBLY TO BE PROPERLY WORKING. HOWEVER, DRIED SALINE DEPOSITS WERE OBSERVED ECG AND PRESSURE CONNECTORS ON THE FRONT END BOARD. THE COMPANY REPRESENTATIVE CLEANED THE CONNECTIONS. THE MOST PROBABLE ROOT CAUSE FOR THE MALFUNCTION COULD BE ATTRIBUTED TO SALINE SPILL ON THE CABLES AND CONNECTORS. THE CUSTOMER REPORTED THAT THE CONNECTION TO THE EXTERNAL ECG INPUT WAS LOOSE FITTING THE 1/4 MALE JACK; THE SERVICE REPRESENTATIVE COULD NOT CONFIRM THAT. AS A PREVENTIVE MEASURE AND TO ACCOMMODATE THE CUSTOMER, THE COMPANY REPRESENTATIVE REPLACED THE EXTERNAL CONNECTOR CABLE ASSEMBLY (PART NUMBER: 0012-00-0765) WAS REPLACED. DURING THE SERVICE, THE COMPANY REPRESENTATIVE NOTICED THE LOW VOLUME IN HELIUM TANK AND RECOMMENDED FOR REPLACEMENT. IN ADDITION, ALSO REPLACED HELIUM REGULATOR ASSEMBLY (PART NUMBER: 0119-00-0208) THAT WAS NOTICED TO BE LEAKING. AFTER THE REPAIRS, A FULL CALIBRATION, FUNCTIONAL AND SAFETY TESTS WERE PERFORMED ON THE IABP UNIT. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012. DURING THE COURSE OF REPAIR, A LOANER IABP UNIT (CS300, S/N (B)(4)) WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE DIRECT ECG SIGNAL WAS NOT SHOWING ON THE SCREEN AFTER PLUGGED INTO THE DIRECT ECG CONNECTOR. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506532 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1