BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23520434 · Received November 11, 2025

    Report

    Report Number
    2249723-2025-0004634
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 20, 2025
    Report Date
    April 27, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ADDITIONAL REPORTER NAME IS (B)(6). UPDATED FIELD : B4 , G3 , G6 , H2 , H11 CORRECTED FIELD : B5 , E1 ( EVENT SITE TELEPHONE ) , H6 ( MEDICAL DEVICE ¿ PROBLEM CODE , TYPE OF INVESTIGATION ).

    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 FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED (SYSTEM ERROR #13 OCCURRED UPON RESTART). WHEN CHECKING THE LIFT, THE SOFTWARE COULD NOT BE STARTED AND THE INITIAL SCREEN WAS NOT DISPLAYED. DAMAGE TO THE CAPACITOR ON THE BACKPLANE BOARD WAS ALSO CONFIRMED. THE FSE BACKPLANE BOARD (0670-00-1163) WAS REPLACED AND THE FSE REMOVED DUST FROM UNIT. OPERATION CONFIRMED TO BE GOOD. AFTER EACH OPERATION, WE CHECKED THE OPERATION BASED ON THE INSPECTION RECORD SHEET AND CONFIRMED THAT IT IS CURRENTLY WORKING PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) SHUTDOWN. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS SHUTDOWN AND AFTER RESTART OF THE MACHINE SYSTEM ERROR #13 OCCURRED. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963097 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