BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 24276561 · Received February 6, 2026

    Report

    Report Number
    2249723-2026-0001112
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 28, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    OTHER CONTACT PERSON: (B)(6). OTHER CONTACT PHONE NUMBER: (B)(6). UPDATED FIELD: B4, B5, D5, D9, E1 (INITIAL REPORTER NAME, EVENT SITE EMAIL), E2, E3, E4, G2, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) H11. A GETINGE FIELD SERVICE ENGINEER WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE CHECKED THE MACHINE AND FOUND AN IABP MAY REQUIRED MAINTENANCE ALARM WAS PRESENT. FURTHER INSPECTION OF THE MACHINE SHOWED THE VACUUM SET POINT WAS OUT OF RANGE AND MEASURED AT NEGATIVE 350. THE FSE CLEANED THE VACUUM INLET FILTER THOROUGHLY AND ADJUSTED THE VACUUM REGULATOR OF THE MACHINE. AFTER THESE ACTIONS THE FSE VERIFIED THAT NO ALARMS WERE PRESENT. THE FSE OBSERVED THE EQUIPMENT ON THE SYSTEM TRAINER FOR MORE THAN TWO HOURS AND CONFIRMED THAT THE EQUIPMENT WAS OPERATING WITHIN SPECIFICATIONS. THE EQUIPMENT WAS HANDED OVER TO THE USER IN GOOD WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE GETINGE FSE THAT DURING PM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) MACHINE IS DISPLAYING AN ALARM MESSAGE THAT IABP MAY REQUIRED MAINTENANCE AND ON FURTHER CHECK FOUND VACUUM SET POINT WAS OUT OF RANGE I.E. VACUUM SET POINT WAS -350. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) MACHINE IS DISPLAYING AN ALARM MESSAGE THAT IABP MAY REQUIRED MAINTENANCE AND ON FURTHER CHECK FOUND VACUUM SET POINT WAS OUT OF RANGE I.E. VACUUM SET POINT WAS -350. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343859 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.