BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 24207052 · Received January 29, 2026

    Report

    Report Number
    2248146-2026-0000615
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    September 26, 2025
    Report Date
    February 12, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. IT WAS REPORTED THAT BLOOD ENTERED INTO DEVICE. UPON EXAMINATION OF THE DEVICE, IT WAS OBSERVED THAT BLOOD HAD MIXED INTO THE DEVICE. UPON EXAMINATION, SINCE BLOOD HAD MIXED INTO THE PNEUMATIC INTERFACE MODULE OF THE DEVICE, IT WAS DETERMINED TO BE DEFECTIVE AND MUST BE REPLACED WITH A NEW ONE. THE DEVICE IS DEFECTIVE.

    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 THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2248146-2025-0000701. PLEASE REFER TO MFG REPORT NUMBER 2248146-2025-0000701 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2248146-2026-0000615 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTRA AORTIC BALLOON THERAPY BLOOD ENTERED THE CARDIOSAVE HYBRID DEVICE AND CONTAMINATED THE PNEUMATIC INTERFACE MODULE. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77583 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARDIOSAVE