BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 6866240 · Received September 14, 2017

    Report

    Report Number
    2249723-2017-00482
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 20, 2017
    Report Date
    December 11, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED..

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE HAS ADVISED THAT THE IABP WAS REPAIRED ON SEPTEMBER 12, 2017 AND RELEASED TO THE CUSTOMER FOR RETURN TO CLINICAL SERVICE.

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EVALUATED THE IABP AND OBSERVED BURNT COMPONENTS. SUBSEQUENTLY, THE BURNT COMPONENT (POWER SUPPLY) WAS RETURNED TO OUR NATIONAL REPAIR CENTER (NRC) FOR FAILURE EVALUATION. OUR NRC PERFORMED INSPECTION OF THE POWER SUPPLY AND OBSERVED BURNED COMPONENTS AND CIRCUIT BOARD INSIDE THE POWER SUPPLY. UNFORTUNATELY, THE DAMAGE WAS TOO EXTENSIVE FOR TESTING, FAILURE ANALYSIS OR REPAIR. PER PROCEDURE, THE POWER SUPPLY HAS BEEN SCRAPPED AND RETAINED AT THE NRC. ADDITIONAL INFORMATION ON THE STATUS OF THE IABP WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE TO US.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, SMOKE WAS OBSERVED FROM INSIDE THE INTRA-AORTIC BALLOON PUMP (IABP), AND VENTS OF FAN AND ITS SURROUNDINGS WERE BLACKENED WITH SOOT WHEN THE AC POWER WAS PLUGGED IN. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, SMOKE WAS OBSERVED FROM INSIDE THE INTRA-AORTIC BALLOON PUMP (IABP), AND VENTS OF FAN AND ITS SURROUNDINGS WERE BLACKENED WITH SOOT WHEN THE AC POWER WAS PLUGGED IN. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, SMOKE WAS OBSERVED FROM INSIDE THE INTRA-AORTIC BALLOON PUMP (IABP), AND VENTS OF FAN AND ITS SURROUNDINGS WERE BLACKENED WITH SOOT WHEN THE AC POWER WAS PLUGGED IN. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646917 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1