BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21695584 · Received March 26, 2025

    Report

    Report Number
    2249723-2025-0001429
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 13, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: D5 GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD LOOSE FIBER OPTIC CONNECTION AND WAS CAUSING THE FIBER OPTIC TO DROP OUT. FSE REPLACED THE FIBER OPTIC EXTENSION ASSEMBLY (0012-00-1562). FUNCTIONAL TESTED WITHOUT ANY FURTHER ISSUES. ALL WORK WAS PERFORMED ON THE MAINTENANCE. SERVICES COMPLETED. SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. NO PATIENT INVOLVEMENT AND NO INDICATION OF ACTUAL OR POTENTIAL HARM OR DEATH.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (RETURN TO MANUFACTURE DATE), G3, G6, H2, H6 (INVESTIGATION CONCLUSIONS). GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD LOOSE FIBER OPTIC CONNECTION AND WAS CAUSING THE FIBER OPTIC TO DROP OUT. FSE REPLACED THE FIBER OPTIC EXTENSION ASSEMBLY (0012-00-1562). FUNCTIONAL TESTED WITHOUT ANY FURTHER ISSUES. ALL WORK WAS PERFORMED ON THE MAINTENANCE. SERVICES COMPLETED. SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. NO PATIENT INVOLVEMENT AND NO INDICATION OF ACTUAL OR POTENTIAL HARM OR DEATH. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0012-00-1562 WITH A REPORTED UNIT FAILURE OF A LOOSE FIBER OPTIC CONNECTION WOULD CAUSE THE SIGNAL TO DROP OUT. 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. NO FAILURE CONFIRMED AFTER MULTIPLE FIBER OPTIC TESTS RUN. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU.

    Description of Event or Problem · 0

    DURING PREVENTIVE MAINTENANCE PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), A LOOSE FIBER OPTIC CONNECTION WAS IDENTIFIED IN THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319695 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.