BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23887157 · Received December 24, 2025

    Report

    Report Number
    2249723-2025-0005242
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 1, 2025
    Report Date
    February 5, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E3, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE). THE FSE WAS INFORMED THAT THE UNIT WAS SET UP WITH A SALINE BAG AND THEN WAS LEFT OVER THE WEEKEND. ON THE FOLLOWING MONDAY, IT WAS FOUND THAT THE SALINE BAG HAD LEAKED ONTO AND INTO THE UNIT DAMAGING THE POWER MANAGEMENT BOARD AND THE MOTOR CONTROL BOARD WHICH WERE BOTH REPLACED BY THE FSE. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND APPROVED FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART PCB, MOTOR CONTROL, ROHS_SWEMCO. PART PCB, POWER MANAGEMENT, ROHS 18 01626 36_SWEMCO. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF PARTS DAMAGED DUE TO SALINE BAG SPILL ON UNIT. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF THE BOARDS AND OBSERVED SALINE DAMAGE TO PART PCB, MOTOR CONTROL, ROHS_SWEMCO AND PART PCB, POWER MANAGEMENT, ROHS_SWEMCO. DUE TO THE DAMAGE TO THE BOARDS, THE BOARDS CANNOT BE INVESTIGATED ANY FURTHER. RETAINING THE BOARDS IN THE FAT DEPT. PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E.1.: 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 CARDIOSAVE HYBRID, TYPE B PLUG INTRA-AORTIC BALLOON PUMP (IABP) WAS UNABLE TO POWER ON DUE TO POSSIBLE LIQUID CONTAMINATION. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421337 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