BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22410403 · Received July 7, 2025

    Report

    Report Number
    2249723-2025-0002903
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 20, 2025
    Report Date
    November 17, 2025
    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 FIELD: B4, G3, G6, H2, H3, D9, H11, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). THE FOLLOWING WAS PERFORMED BY (B)(4) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT, WAYNE, NJ: (B)(4) 06 NOV 2025. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0997-00-1178 SN: (B)(6) PNEUMATIC MODULE ASSY. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿SHUTTLE TRANSDUCER NOT ZEROING¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND THE PART WAS FOUND TO BE IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF MECHANICAL DAMAGE AND CONTAMINATION OBSERVED. INSTALLED PNEUMATIC MODULE ASSY. INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. THE FAT DEPARTMENT PERFORMED STANDARD FUNCTIONAL TESTS AND PASSED. THE FAT DEPT. COULD NOT REPLICATE THE FAILURE MESSAGE OF ¿SHUTTLE TRANSDUCER NOT ZEROING¿. PNEUMATIC MODULE ASSY. PASSED TESTING. RETAINING PNEUMATIC MODULE ASSY. IN THE FAT DEPT. PER PROCEDURE (B)(4). A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SHUTTLE PRESSURE WOULD NOT ZERO. FSE REPLACED THE PNEUMATIC INTERFACE MODULE (B)(4) AND CALIBRATED. FUNCTIONAL TESTED WITHOUT ANY FURTHER ISSUES. ALL WORK WAS PERFORMED ON MAINTENANCE SO# (B)(4) CARDIOSAVE IABP SERVICES COMPLETED. FULL PM, SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SEMI ANNUAL MAINTENANCE THE CARDIOSAVE INTRA AORTIC BALLOON PUMP( IABP) SHUTTLE TRANSDUCER WAS NOT ZEROING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281260 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.