BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 7015920 · Received November 9, 2017

    Report

    Report Number
    2249723-2017-00769
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Report Date
    December 8, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) IS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED, INSPECTED THE IABP AND FOUND THAT THE IABP WOULD NOT POWER UP AT ALL AND WOULD GO DIRECTLY INTO AN ALARM. THE POWER SUPPLY HAD NO SUPPLY VOLTAGE BEING DISTRIBUTED. THE FSE ORDERED THE POWER SUPPLY AND RETURNED TO REPLACE IT. THE FSE INSTALLED THE NEW POWER SUPPLY AND TESTED THE IABP FOR PERFORMANCE AND SAFETY. ALL PERFORMANCE AND SAFETY TESTS PASSED AND THE IABP WAS APPROVED FOR CLINICAL USE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A MONITOR RELATED ISSUE. THE CIRCUMSTANCES OF THE EVENT ARE UNKNOWN, HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ALSO, NO ADVERSE EVENT HAS BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A MONITOR RELATED ISSUE. THE CIRCUMSTANCES OF THE EVENT ARE UNKNOWN, HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ALSO, NO ADVERSE EVENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795446 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1