BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22261076 · Received June 18, 2025

    Report

    Report Number
    2249723-2025-0002633
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 26, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DUE TO CHARACTERIZATION LIMIT E1 (INITIAL REPORTER: (B)(6)). CONTACT PERSON NAME: (B)(6). CONTACT PERSON E-MAIL ADDRESS: (B)(6). CONTACT PERSON PHONE NUMBER: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(RETURN TO MANUFACTURE DATE), E1 (EVENT SITE E MAIL), G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). CORRECTED FIELDS: G2 A GETINGE FIELD SERVICE ENGINEER (FSE) STATES, FOUND BROKEN FIBER OPTIC CONNECTION DURING PM. REPLACED FIBER OPTIC PORT WHICH RESOLVED THE ISSUE. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER WITH A REPORTED UNIT FAILURE OF A DAMAGED FIBER OPTIC CONNECTION PORT. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A DAMAGED FIBER OPTIC CONNECTOR HOUSING. SEE ATTACHMENT. FAILURE CONFIRMED BUT ROOT CAUSE IS IMPOSSIBLE TO DEFINE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE FST (FEILD SERVICE TECHNICIAN) THAT DURING PREVENTIVE MAINTENANCE THE FIBER OPTIC CONNECTION PORT OF CARDIOSAVE IABP (INTRA-AORTIC BALLOON PUMP) WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637006 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 AS NO PATIENT INVOLVED.