BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4030741 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01062
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, THE "NO PT STATUS AVAILABLE" ALARMS WERE LOGGED IN THE FAULT LOG. THE COMPANY REP REPLACED THE KEYPAD CONTROLLER PCB (PART NUMBER 0670-00-1145) AND THE IABP COILED CABLE (PART NUMBER 0012-00-1422). THE COMPANY REP PERFORMED CALIBRATION AND FUNCTIONAL TESTS. THE IABP MET FACTORY SPECS AND WAS RETURNED TO THE CUSTOMER. NOTE: THIS EVENT ON THE SAME IABP HAS BEEN REPORTED EARLIER. REFER TO (B)(4) (MDR 2249723-2014-00899). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT DISPLAYED A "PT DATA NOT AVAILABLE" MESSAGE AND AN ALARM TONE WAS GENERATED. THE CUSTOMER RESTARTED THE IABP THREE TIMES, BUT THE ALARM PERSISTED. THE IABP UNIT WAS REPLACED AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442922 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1