BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM

    MDR report key: 17170533 · Received June 21, 2023

    Report

    Report Number
    2249723-2023-02874
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    June 12, 2023
    Report Date
    April 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108674
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    EVENT SITE POSTAL CODE AND STATE : (B)(6). IT WAS REPORTED THAT DURING THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DEFECTIVE SCREEN DISPLAY. A GETINGE FIELD SERVICE ENGINEER (FSE) REPORT OF SCREEN DISPLAY FAILURE OCCURRENCE DATE UNKNOWN. THE SCREEN IS DISTORTED WHEN THE POWER IS TURNED ON. # 6/9 WHEN THE ENGINEER CHECKED, THERE WAS A SIMILAR SYMPTOM (THE SCREEN TURNED WHITE). TAP THE BACK OF THE MONITOR TO IMPROVE THE DISPLAY. THE VIDEO RECEIVER BOARD (D670-00-0736) AND FLAT CABLE WERE REPLACED (D012-00-1429), AND IT WAS RETURNED AFTER CONFIRMING THAT IT STARTED NORMALLY. THE DEVICE HAS BEEN DELIVERED TO THE CUSTOMER AND IS READY FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED PN 0670-00-0736 INTO CS300 TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(6) REVISION E AND THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE FOUND. INSTALLED PN 0012-00-1429 INTO CS300 TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION E AND THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE FOUND. FAT COULD NOT VERIFY THE REPORTED FAILURE FOR ANY OF THESE PARTS. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4) REV. AP. 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 DURING START UP, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN S BLACK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207317 CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-UC-3013-65 10607567108674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown