BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23655796 · Received November 26, 2025

    Report

    Report Number
    2249723-2025-0004838
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 20, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS: E1. DUE TO CHARACTER LIMIT IN E1.: FULL INITIAL REPORTER'S NAME: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT. THE FSE REPORTED THAT THE MEMBRANE LEAK DIFF. PRESSURE WAS CONSISTENTLY FAILING. THE SAFETY DISK (0202-00-0140) AND PIM ASSEMBLY (0997-00-1178) WAS REPLACED DUE TO AN UNPLUG MESSAGE APPEARING AT THE START OF THE LEAK TEST DESPITE NO LURE PLUG BEING CONNECTED. THE TIDAL VOLUME DISK, AND O-RING WERE REPLACED AS A PART OF MAINTENANCE. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0202-00-0140 REV K, SN: (B)(6). SAFETY DISK. PN: 0997-00-1178 SN: (B)(6). PNEUMATIC MODULE ASSY. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿LEAK TEST FAILURE.¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND THE PARTS WERE FOUND TO BE IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF MECHANICAL DAMAGE AND CONTAMINATION OBSERVED. INSTALLED SAFETY DISK AND PNEUMATIC MODULE ASSY, INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TOGETHER AND SEPARATELY TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. PERFORMED FUNCTIONAL TESTS AND ALL MANIFOLD LEAK TESTS. THE FAT DEPT. VERIFIED THE FAILURE MESSAGE OF ¿LEAK TEST FAILURE¿ WITH RESULT OF MEMBRANE LEAK 7MMHG. DURING SEPARATELY TESTED OF BOTH PARTS, THE FAT COULD NOT VERIFY THE FAILURE MESSAGE OF ¿LEAK TEST FAILURE¿ FOR PNEUMATIC MODULE ASSY. HOWEVER, SAFETY DISK WAS FAILED WITH RESULT OF MEMBRANE LEAK TEST 7MMHG. RETAINING BOTH PARTS IN THE FAT DEPT. PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME- (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SAFETY DISK LEAK TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946538 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.