BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 21959483 · Received May 5, 2025

    Report

    Report Number
    2249723-2025-0002074
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, FULL EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION - B4, G3, G6, H2, H3, H6, H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPAIRING THE EQUIPMENT ON SITE, FOUND THAT THERE WAS NO COUNTER PULSATION AFTER STARTING THE EQUIPMENT, AND THE BALLOON WAS REFILLED WITH GAS. THE BALLOON WAS CONNECTED ON SITE FOR TESTING, AND NO FAULTS WERE FOUND. THE FRONT BOARD, BACK BOARD, CONTROL BOARD AND OTHER CIRCUIT BOARDS WERE UNPLUGGED AND RECONNECTED. THE BALLOON WAS TESTED CONTINUOUSLY FOR SEVERAL HOURS, AND NO FAULTS WERE FOUND. ALL FUNCTIONS AND SAFETY TESTS WERE PERFORMED, AND ALL PARAMETERS MET FACTORY REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE FIELD SAFETY TECHNICIAN DURING CONDUCTING ROUTINE INSPECTIONS ON CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) AFTER CONNECTING THE BALLOON TO START THE TEST, THE PROMPT "AUTOMATIC INFLATION COMPLETED" APPEARED, BUT THE BALLOON WAS NOT INFLATED AND IT WAS A STRAIGHT LINE. AFTER SHUTTING DOWN AND RESTARTING, IT WORKED NORMALLY. THERE WERE NO PATIENTS INVOLVED AND NO CASUALTIES REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873162 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown