BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 23954554 · Received January 5, 2026

    Report

    Report Number
    2249723-2026-0000142
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 15, 2025
    Report Date
    March 18, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, AN EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THIS IS A NON-REPORTABLE EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. THIS REPORT 2249723-2026-0000142 PLEASE CANCEL IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    CORRECTION FIELD: E1(EVENT SITE NAME, EVENT SITE ADDRESS). UPDATED FIELD: B4, D9, E1(INITIAL REPORTER NAME, PHONE, EMAIL), G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES INVESTIGATION CONCLUSIONS), H11 A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THE HELIUM CAP ON THE TROLLEY WAS FOUND TO BE BROKEN AND THE AFFECTED PART WAS REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) HELIUM CAP DOES NOT STAY IN PLACE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29445 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.