BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 23847212 · Received December 19, 2025

    Report

    Report Number
    2248146-2025-0000851
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    August 30, 2025
    Report Date
    February 12, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: H11 REVERT ALL SECTIONS TO BLANK: B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2248146-2025-0000769. PLEASE REFER TO MFG REPORT NUMBER 2248146-2025-0000769 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2248146-2025-0000851 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9,G3, G6,H2, H3, H6(MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS),H11. NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. THEREFORE, WE WERE UNABLE TO CONFIRM OR DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. THE FAILURE MODE IS ADDRESSED IN IN ALL IAB RISK FILES . ALL IAB IFUS ADDRESS THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. EACH IAB MANUFACTURED IS 100% INSPECTED AND THE CONTROLS PUT IN PLACE DURING THE MANUFACTURING OF THE IAB WOULD CATCH A DEFECT AND NOT ALLOW NON-CONFORMING DEVICE TO BE RELEASED. BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED AS PART OF CAPA 1357192 TO ENSURE THE CORRECT NUMBER OF COMPLAINTS ARE INITIATED FOR RELATED EVENTS. UPON REVIEW OF THIS COMPLAINT, AN ADDITIONAL COMPLAINT WAS IDENTIFIED AND OPENED, WHICH WAS DETERMINED TO BE REPORTABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REVERT ALL SECTIONS TO BLANK : B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THE BATTERY WAS EXPIRED. NO OTHER MALFUNCTION IDENTIFIED. HENCE THE COMPLAINT IS INVALID AND NO FOLLOW UP REPORT IS NECESSARY. IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2248146-2025-0000769. PLEASE REFER TO MFG REPORT NUMBER 2248146-2025-0000769 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2248146-2025-0000851 IN YOUR DATABASE.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTRA-AORTIC BALLOON (IAB) THERAPY THAT THE FSE ENCOUNTERED AN "AUTOFILL FAILURE" ALARM ON THE MACHINE. NO PATIENT HARM WAS REPORTED ON-SITE. UPON INVESTIGATION, IT WAS DISCOVERED THAT BLOOD HAD ENTERED THE MACHINE, REACHING COMPONENTS SUCH AS THE SAFETY DISK, CRM, BLOOD-DETECTING TUBE, PURGE ASSEMBLY, AND THE RESERVOIR.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55820 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CS300.