BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22951248 · Received September 3, 2025

    Report

    Report Number
    2249723-2025-0003712
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    March 7, 2025
    Report Date
    November 4, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION IN BLOCK E1 EVENT IS NAME IS (B)(6), E1 EVENT SITE ADDRESS IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THE REPORTED FAILURE HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0003724 AND THIS WAS ONLY A ROUTINE SAFETY DISK REPLACEMENT. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0003724 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0003712 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PM, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISK IS DUE FOR REPLACEMENT AND HELIUM FLOWING FASTER THAN SPECIFIED. THERE WAS NO PATIENT INVOLVED AND NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474172 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.