BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22975954 · Received September 5, 2025

    Report

    Report Number
    2249723-2025-0003736
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 18, 2025
    Report Date
    February 14, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9E1 (EMAIL), H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT AND THE PROBLEM WAS FOUND AS REPORTED. THE FSE REPLACED THE ASSY, DISPLAY TOP LCD ROHS (0160-00-0127) AND THE DEVICE RETURNED TO EXPECTED USE. THE FSE CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.THE FOLLOWING WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ: (B)(4) 10 OCT 2025. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT:PN: 0160-00-0127 REV N/A, SN: N/A. DISPLAY TOP LCD. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF DISPLAY SHOWING NOTHING BUT A GRAY SCREEN. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION, AND PART LOOKS IN GOOD CONDITION. INSTALLED DISPLAY TOP LCD INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TO THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. THE FAT DEPT. VERIFIED THE FAILURE MESSAGE OF DISPLAY SHOWING NOTHING BUT GRAY SCREEN AS SOON AS CARDIOSAVE TEST FIXTURE TURNED ON. PLEASE SEE ATTACHED PICTURE. DISPLAY TOP LCD FAILED TESTING. RETAINING DISPLAY TOP LCD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP HALF OF THE SCREEN OF CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT WORKING DURING DAILY CHECKS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132685 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.