BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23435501 · Received October 31, 2025

    Report

    Report Number
    2249723-2025-0004503
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 10, 2025
    Report Date
    January 21, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD - G3. A GETINGE FIELD SERVICE ENGINEER (FSE) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) A GOUGE WAS DISCOVERED IN THE HIGH-PRESSURE REGULATOR ASSEMBLY AT THE HELIUM TANK SEATING AREA. THE FSE REPLACED THE HIGH-PRESSURE REGULATOR ASSEMBLY (D103-00-0637) AND CONDUCTED FUNCTIONAL TESTING WITH NO ISSUES OBSERVED. ALL WORK WAS PERFORMED UNDER MAINTENANCE SO# (B)(4). THE UNIT PASSED ALL SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS ACCORDANCE WITH FACTORY SPECIFICATIONS. NO PATIENT INVOLVED AND HARM REPORTED. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0103-00-0637 WITH A REPORTED UNIT FAILURE OF A GOUGE AT THE HELIUM TANK SEAT. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE DAMAGED AT THE HELIUM TANK NOZZLE. THIS WOULD MOST LIKELY CAUSE A HELIUM LEAK. CONFIRMED THE FAILURE WITH PROBABLE CAUSE BEING A USER ERROR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    ADDITIONAL POINT OF CONTACT: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (COMPONENT CODE), H11. CORRECTED FIELDS: H6 (INVESTIGATION FINDINGS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HIGH PRESSURE REGULATOR HAD GOUGE AT THE TANK SEAT. FOUND DURING PM. NO PATIENT INVOLVED. NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55708 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.