BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24243444 · Received February 3, 2026

    Report

    Report Number
    2249723-2026-0001043
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 4, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER CONTACT PERSON: (B)(6) -RN. DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2026-0001093. PLEASE REFER TO MFG REPORT NUMBER 2249723-2026-0001093 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2026-0001043 IN YOUR DATABASE.

    Description of Event or Problem · 0

    AN ICU RN, (B)(6), REPORTED A LOW HELIUM ALARM ON A CARDIOSAVE AFTER CHANGING THE HELIUM TANK TWICE. THE DEVICE WAS IN STANDBY FOR 22 MINUTES, AND THE SCREEN FROZE WHEN INSTRUCTED TO PRESS START. ESP PERSONNEL ADVISED SWITCHING TO ANOTHER CARDIOSAVE, WHICH WAS SUCCESSFULLY DONE BEFORE CRITICAL BALLOON CATHETER INACTIVITY. FURTHER TROUBLESHOOTING REVEALED THE HELIUM TANK VALVE WAS NOT FULLY OPENED, BUT THE ALARM PERSISTED WITH A RED HELIUM ICON. AFTER THE SWITCH, THE FIRST PUMP WAS POWERED OFF AND ON, SHOWING A GREEN HELIUM ICON. THE PUMP WAS SENT TO BIOMED WITH A NOTE ABOUT A FROZEN TOUCHSCREEN, AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586679 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 71 YR Male UNKNOWN.