BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 8723275 · Received June 21, 2019

    Report

    Report Number
    2249723-2019-00993
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    January 28, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE MAIN BOARD AND THE SOLENOID DRIVER BOARD AND ALL SPARE PARTS; HOWEVER, THE CUSTOMER'S REPORTED ISSUE WAS NOT RESOLVED. THE IABP UNIT REMAINS OUT OF USE PENDING FURTHER EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THREE (3) GOOD FAITH EFFORTS (GFES) TO OBTAIN THE RELEVANT REPAIR AND IABP STATUS RELATED TO THIS COMPLAINT ISSUE WERE MADE. HOWEVER, DESPITE OUR BEST EFFORTS, NO RESPONSE HAS BEEN RECEIVED TO ANY OF OUR GFES. IF ADDITIONAL INFORMATION IS PROVIDED, WE WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER BEING IN DEACTIVATED MODE FOR MANY MONTHS UPON POWER-UP WHEN THE ¿ON¿ SWITCH WAS PRESSED, THE LIGHT FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WOULD BLINK AND THE IABP UNIT WOULD IMMEDIATELY TURN OFF. IT WAS NOTED THAT THE COOLING FAN WAS WORKING PERFECTLY AND THE SOLENOID PAPER CIRCUIT BOARD (PCB) AND MAIN BOARD WERE CROSS CHECKED WITH NO ISSUES. THE BATTERY WAS CHECKED AND CHARGED FOR A DAY; HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER BEING IN DEACTIVATED MODE FOR MANY MONTHS UPON POWER-UP WHEN THE ¿ON¿ SWITCH WAS PRESSED, THE LIGHT FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WOULD BLINK AND THE IABP UNIT WOULD IMMEDIATELY TURN OFF. IT WAS NOTED THAT THE COOLING FAN WAS WORKING PERFECTLY AND THE SOLENOID PAPER CIRCUIT BOARD (PCB) AND MAIN BOARD WERE CROSS CHECKED WITH NO ISSUES. THE BATTERY WAS CHECKED AND CHARGED FOR A DAY; HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS 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. THE FULL NAME OF THE EVENT SITE WAS SHORTENED DUE TO FIELD CHARACTER LIMIT; THE FULL NAME IS (B)(6) HOSPITAL. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BEING IN DEACTIVATED MODE FOR MANY MONTHS UPON POWER-UP WHEN THE ¿ON¿ SWITCH WAS PRESSED, THE LIGHT FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WOULD BLINK AND THE IABP UNIT WOULD IMMEDIATELY TURN OFF. IT WAS NOTED THAT THE COOLING FAN WAS WORKING PERFECTLY AND THE SOLENOID PAPER CIRCUIT BOARD (PCB) AND MAIN BOARD WERE CROSS CHECKED WITH NO ISSUES. THE BATTERY WAS CHECKED AND CHARGED FOR A DAY; HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516071 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1