BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 7350369 · Received March 19, 2018

    Report

    Report Number
    2249723-2018-00434
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 27, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. THE CUSTOMER WILL BE COMPLETING ALL THE REPAIRS THEMSELVES. A NEW POWER SUPPLY WAS ORDERED TO REPLACE THE CURRENT ONE, AND THEN THE IABP WILL BE CLEARED FOR CLINICAL USE. IF THE CUSTOMER NEEDS FURTHER ASSISTANCE, A COMPANY REPRESENTATIVE WILL BE DISPATCHED TO ASSIST. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A GETINGE COMPANY REPRESENTATIVE REPORTED THAT AS A COURTESY, IN RELATION TO THIS REPORTED EVENT, A "BLOOD DETECT TUBING"" COMPONENT WAS GIVEN TO THE CUSTOMER. FURTHERMORE, THE CUSTOMER REPORTED THAT THE REPAIRS WERE COMPLETED ON THE INTRA-AORTIC BALLOON PUMP. THE IABP WAS THEN CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK, PERFORMED BY THE CUSTOMER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND TO HAVE THE FAN ON THE POWER SUPPLY DAMAGED. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK, PERFORMED BY THE CUSTOMER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND TO HAVE THE FAN ON THE POWER SUPPLY DAMAGED. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194015 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1