BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4030620 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-00960
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    March 17, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP INSPECTED THE UNIT AND DID NOT OBSERVE ANY SIGN OF BLOOD IN THE UNIT. THE ALARM CODE WAS OPTICAL. THE COMPANY REP NOTICED THAT THE TP4 TO TP5 ON SOLENOID DRIVER BOARD WAS OUT OF SPECIFICATION OF 3.0 VOLTS. THE BLOOD BACK ALARM WAS NOT DUPLICATED BY THE COMPANY REP. THE SOLENOID DRIVER BOARD (PART NUMBER 0670-00-0638) WAS REPLACED. THE COMPANY REP PERFORMED FUNCTIONAL TESTS AND SAFETY CHECKS. THE UNIT MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED "BLOOD BACK" ALARM. THE IABP AND THE BALLOON WERE REPLACED AND THE THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442692 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR