BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23119616 · Received September 23, 2025

    Report

    Report Number
    2249723-2025-0003951
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 2, 2025
    Report Date
    January 7, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1(EVENT SITE EMAIL),G6,H2,H11. CORRECTED FIELDS: D9, E1(INITIAL REPORTER), H6(TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS),H11. IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD REPORTED A GAS LOSS ALARM. CUSTOMER STATED THAT CARDIOSAVE WAS DISPLAYING GAS LOSS. UNABLE TO DUPLICATE PROBLEM NO SIGNIFICANT ERRORS IN LOGS. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED UNDER MFG REPORT NUMBER 2249723-2025-0003951. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0003951 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E2, E3, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. THE COMPLAINT WILL BE UPDATED UPON ADDITION OF NEW INFORMATION. INFORMATION REGARDING IF A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT IS STILL PENDING AND WILL BE ADDED UPON RESPONSE FROM CUSTOMER.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H3, H6(HEALTH EFFECT ¿ CLINICAL CODE), H11 CORRECTED FIELD - H6 (INVESTIGATION CONCLUSIONS) IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD REPORTED A GAS LOSS ALARM. INFORMATION REGARDING PATIENT HARM OR SERIOUS INJURY WAS ASKED IN MULTIPLE GOOD FAITH EFFORTS (GFES) AND THE COMPLAINT WILL BE UPDATED UPON ADDITION OF NEW INFORMATION. INFORMATION REGARDING IF A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT IS STILL PENDING AND WILL BE ADDED UPON RESPONSE FROM CUSTOMER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER STATED THAT CARDIOSAVE WAS DISPLAYING GAS LOSS. UNABLE TO DUPLICATE PROBLEM NO SIGNIFICANT ERRORS IN LOGS.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED FOR GAS LOSS. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63879 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.