BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 23323720 · Received October 17, 2025

    Report

    Report Number
    2249723-2025-0004350
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 30, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD : B4 , G3 , G6 , H2 , H11 , E1 ( EVENT SITE EMAIL ) CORRECTED FIELD : D10 , H6 ( MEDICAL DEVICE ¿ PROBLEM CODE ).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION CONCLUSIONS). FULL EVENT SITE NAME: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE REPORTED BUT FOUND THAT THE FRONT-END BOARD IS OUT OF ORDER. THE FRONT-END BOARD (0670-00-1164) WAS REPLACED BY THE FSE AND TEST WERE PERFORMED. THE UNIT PASSED ALL PERFORMANCE ACCORDING TO FACTORY SPECIFICATIONS AND CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: (B)(6) ON (B)(6) 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-0769 WITH A REPORTED UNIT FAILURE OF SYSTEM HANGUP DURING STARTUP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD 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. ALL TESTING PASSED. NO FAILURE CAN BE CONFIRMED FOR THIS PART. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING STARTUP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A SYSTEM HANG. NO PATIENT WAS INVOLVED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING START UP THE CADIOSAVE INTRA AORTIC BALLOON PUMP (IABP) SYSTEM HANG UP "FROZE" ON THE "MAQUET" LOGO. IT FAILED TO ENTER "STANDBY" MODE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827732 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.