BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 22948990 · Received September 2, 2025

    Report

    Report Number
    2249723-2025-0003702
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 13, 2025
    Report Date
    December 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6). UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: E1 (EVENT SITE NAME, EVENT SITE TELEPHONE). A GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS A HELIUM GAS LEAK FROM THE CART. THE FSE REPLACED THE HELIUM HIGH PRESSURE REGULATOR (0103-00-0637). THE CONSOLE WAS INSPECTED ACCORDING TO SERVICE MANUAL AND FOUND TO BE IN GOOD CONDITION. THERE WAS NO PATIENT INVOLVEMENT. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 30 OCT 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0103-00-0637 WITH A REPORTED UNIT FAILURE OF A HELIUM LEAK. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. ALL TESTING PASSED. NO FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INSPECTION BY HOSPITAL STAFF, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HISSING SOUND OF GAS LEAKING FROM NEAR A HELIUM GAS CYLINDER WAS DISCOVERED AND HELIUM GAS WAS LEAKING FROM CART. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734639 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown