BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 23836779 · Received December 18, 2025

    Report

    Report Number
    2249723-2025-0005163
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 28, 2025
    Report Date
    January 28, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9, H3, H6. (TYPE OF INVESTIGATION, HEALTH EFFECT ¿ IMPACT CODES, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). CORRECTED FIELD: E2, E3, E4, D5, G2. A GETINGE FIELD SERVICE ENGINEER (FSE) STATED THAT NEED FLAT CABLE (0012-00-1158) FOR TESTING PURPOSE. ON RECONNECTED ALL DISPLAY CONNECTION. UNIT OBSERVED FOR MORE THAN 4 HRS. UNIT HANDOVER TO CUSTOMER IN WORKING WELL CONDITION. AGAIN, SAME PROBLEM WAS PERSISTING. FSE VISITED THE SITE ON 16-12-2025 AND CHECKED THE DEVICE. FSE REPLACED THE (D012-00-1558) CABLE ASSY UPPER DISPLAY TO MONITOR WITH NEW ONE AND RECTIFIED THE ISSUE. DEVICE PASSED THE ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. OBSERVED THE DEVICE FOR 3 HOURS, NO ERRORS & PROBLEMS HAD OCCURRED AGAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVEINTRA-AORTIC BALLOON PUMP (IABP) HAD FLICKERING DISPLAY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336633 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown