BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22935940 · Received September 2, 2025

    Report

    Report Number
    2249723-2025-0003684
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS -B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. THE GETINGE FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE AN ISSUE WITH THE FIBER OPTIC. THE FSE FOUND WHEN SEATING THE FIBER OPTIC CONNECTOR INTO THE SOCKET IT HAD A LITTLE BIT OF PLAY AND INTERMITTENTLY WOULD DROP OUT AND ZERO PRESSURE. THE CBL ASSY,FO SENSOR EXTENSION (0012-00-1562). THE DEVICE SUCCESSFULLY PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY INDICATORS.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9. CORRECTED DATA: H6 (INVESTIGATION FINDINGS, CONCLUSION, COMPONENT CODE). THE GETINGE FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE AN ISSUE WITH THE FIBER OPTIC. THE FSE FOUND WHEN SEATING THE FIBER OPTIC CONNECTOR INTO THE SOCKET IT HAD A LITTLE BIT OF PLAY AND INTERMITTENTLY WOULD DROP OUT AND ZERO PRESSURE. THE CBL ASSY, FO SENSOR EXTENSION (0012-00-1562). THE DEVICE SUCCESSFULLY PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY INDICATORS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 11 NOV 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0012-00-1562 WITH A REPORTED UNIT FAILURE OF THE FIBER OPTIC CONNECTION IS RESET WHEN TOUCHING THE MALE FIBER OPTIC CONNECTOR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER: (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER: 0070-00-0639 REVISION R. THE FAILURE CANNOT BE REPLICATED AND IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    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

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FIBER OPTIC WAS NOT WORKING AND IT MIGHT BE A BALLOON CATHETER ISSUE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087542 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 BALLOON CATHETER.