BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 22672624 · Received July 30, 2025

    Report

    Report Number
    2249723-2025-0003271
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 21, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME: NATIONAL HEART CENTRE OF SINGAPORE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE COMPLAINT WAS CREATED IN ERROR, THERE WAS NO REPORTED CUSTOMER DISSATISFACTION RELATED TO THIS EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MFG REPORT NUMBER - 2249723-2025-0003271 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE/CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD ANBATTERY MAINTENANCE ERROR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496727 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A - NO PATIENT INVOLVEMENT.