BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V

    MDR report key: 15031335 · Received July 15, 2022

    Report

    Report Number
    2249723-2022-01729
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 28, 2022
    Report Date
    April 25, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107684
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATIONS: E1 (STATE: (B)(6)). THE IABP UNIT WAS INSPECTED AT GETINGE SERVICE CENTER AFTER RETURNING FROM THE FACILITY. THE REPORTED ISSUE WAS CONFIRMED TO BE REPLICATED. AFTER SOLENOID DRIVER BOARD WAS REPLACED TO ANOTHER ONE, THE ISSUE WAS RESOLVED. AFTER REPLACING OF THE BOARD, PREVENTIVE MAINTENANCE INCLUDING SYSTEM FUNCTIONAL CHECK, ELECTRICAL SAFETY TEST AND A LONG-TERM RUNNING TEST WAS PERFORMED NORMALLY. THE REPAIR OF THIS IABP UNIT WAS COMPLETED ON 7 JULY 2022. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE NATIONAL REPAIR CENTER INSTALLED THE SOLENOID DR BOARD AND TESTED THE SOLENOID DRIVER BD. AS PER THE CS100 SERVICE MANUAL . THE NRC WAS ABLE TO VERIFIED THE FAILURE OF THE SOLENOID DRIVER BD. DURING THE INITIAL INVESTIGATION THE PROBLEM OF NO POWER UP OF SYSTEM WAS VERIFIED. SENDING THE SOLENOID DRIVER BD. TO THE SUPPLIER FOR FAILURE INVESTIGATION AS PER PROCEDURE . THE FOLLOWING WAS SUBMITTED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (B)(6). PART NO LONGER ABLE TO BE TESTED BY THE SUPPLIER. INVESTIGATION IS COMPLETE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO DEFINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO AN EMERGENCY CASE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS STARTED UP. THEN ON JUNE 28TH, THE POWER SUPPLY SHUTDOWN AND THE DRIVE STOPPED WORKING WITH NO ALARM SOUNDING. SINCE THE POWER DID NOT TURN ON AND THE UNIT COULD NOT BE RESTARTED, THE CUSTOMER REPLACED IT WITH ANOTHER UNIT AND RESTARTED, STATING THAT IT TOOK ABOUT 20 MINUTES TO RESUME. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS PATIENT INVOLVEMENT. THIS IS AN AUTOMATED DRAFT TRANSLATION - IF ANY UNCERTAINTY CONTACT THE LOCAL SSU IMMEDIATELY: GETINGE GROUP JAPAN CO., LTD., OCCURRED ON FIXED ASSET MACHINES. ON JUNE 26, IABP DRIVE WAS STARTED IN AN EMERGENCY CASE. JUNE 28, 5:20 AM, THE POWER SUPPLY SHUT DOWN AND THE DRIVE STOPPED (NO ALARM SOUND). SINCE THE POWER DID NOT TURN ON AND IT COULD NOT BE RESTARTED, IT WAS REPLACED WITH ANOTHER DEVICE AND RESTARTED. IT TOOK ABOUT 20 MINUTES TO RESUME.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723273 CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-65 10607567107684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INTRA-AORTIC BALLOON PUMP UNIT.