BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 15074970 · Received July 21, 2022

    Report

    Report Number
    2249723-2022-01831
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    July 8, 2022
    Report Date
    March 27, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL FIELDS: E1(EVENT SITE EMAIL: (B)(6)). IT WAS REPORTED THAT THE DEVICE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCRAMBLED DISPLAY SCREEN. CUSTOMER REPORTED SCREEN ISSUES WHILE TRAINING. GETINGE FIELD SERVICE ENGINEER (FSE) TURNED UNIT ON AND WAS ABLE TO REPRODUCE THE COMPLAINT. REPLACED COILED CABLE (D012-00-1422), VIDEO RECEIVER CARD (D670-00-0736), AND KEYPAD CONTROLLER CARD (D012-00-1059). ENSURED SCREEN OPERATED AS IT SHOULD. PERFORMED SYSTEM CHECKOUT AND RELEASED TO CUSTOMER FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE NATIONAL REPAIR CENTER INSTALLED THE COIL CABLE P/N 0012-00-1422, COLOR VIDEO RECEIVER BD. P/N 0670-00-0736 AND KEYPAD CONTROLLER BD. P/N 0670-00-1145 INTO THE CS300 TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE COIL CABLE AS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REVISION V. THE NRC WAS UNABLE TO VERIFIED THE FAILURE OF THE COIL CABLE, COLOR VIDEO RECEIVED AND KEYPAD CONTROLLER BOARD. NO PROBLEM FOUND. RETAINING THE COIL CABLE, COLOR VIDEO RECEIVER AND KEYPAD CONTROLLER BOARD IN THE NRC PER PROCEDURE 0002-07-D008 REV AJ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCRAMBLED DISPLAY SCREEN. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING SESSION THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCRAMBLED DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718929 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown