BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23939367 · Received January 1, 2026

    Report

    Report Number
    2249723-2026-0000030
    Event Type
    Malfunction
    Date Received
    January 1, 2026
    Date of Event
    December 5, 2025
    Report Date
    March 15, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (RETURN TO MANUFACTURE DATE), G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. CORRECTED FIELDS: E1 (INITIAL REPORTER). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE FIBER OPTIC CONNECTION WAS BROKEN. TO REMEDIATE THIS THE FSE REPLACED THE CABLE ASSY, FIBER OPTIC AND FIBER OPTIC JUMPER CABLE. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AS PER MANUFACTURING SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED CBL, ASSY, FO SENSOR EXTENSION WITH A REPORTED UNIT FAILURE OF FIBER OPTIC NOT WORKING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND OBSERVED THE CONNECTOR WAS DAMAGED. PROBABLE CAUSE OF THE FIBER OPTIC NOT WORKING IS THE DAMAGED CONNECTOR. RETAINING THE CABLE IN THE FAT DEPT. PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT PRIOR TO USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) FIBER OPTIC IS NOT WORKING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7 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 NOT APPLICABLE.