BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20256195 · Received September 19, 2024

    Report

    Report Number
    2249723-2024-0003843
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H3, H6 (MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. DUE TO CHARACTER LIMIT IN BLOCK E1 EVENT SITE NAME: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE FIBER-OPTIC SENSOR EXTENSION CABLE (0012-00-1562). DUE TO DAMAGE, THE UPPER PANEL ASSEMBLY (0997-00-0644) WAS ALSO REPLACED. THE FSE PERFORMED A COMPLETE PREVENTIVE MAINTENANCE (PM) WITH FULL CALIBRATION. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0012-00-1562 CABLE ASSEMBLY FIBER OPTIC EXTENSION SERIAL NUMBER (B)(6), PART NUMBER 0997-00-0644 ASSEMBLY, UPPER PANEL SERIAL NUMBER N/A. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF DAMAGE TO THE FIBER BOARD. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND PART NUMBER 0012-00-1562 CABLE ASSEMBLY FIBER OPTIC EXTENSION SERIAL NUMBER (B)(6) TO HAVE DAMAGE OF THE BLUE CONNECTOR, AND PART NUMBER 0997-00-0644 ASSEMBLY, UPPER PANEL SERIAL NUMBER N/A TO HAVE DAMAGE ON THE UPPER RIGHT HAND CORNER OF THE PANEL. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AS. THE MOST PROBABLE ROOT CAUSE FOR THE FIBER-OPTIC SENSOR EXTENSION CABLE IS EXCESSIVE STRESS OR FATIGUE DUE TO A USER ERROR OR EXPECTED WEAR AND TEAR. THE MOST PROBABLE ROOT CAUSE FOR DAMAGED UPPER PANEL ASSEMBLY IS EXCESSIVE EXTERNAL FORCE DUE TO A USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DAMAGED TO FIBER OPTIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK BY CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DAMAGED TO FIBER OPTIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591561 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