BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 21571803 · Received March 11, 2025

    Report

    Report Number
    2249723-2025-0001142
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Report Date
    July 30, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE PARENT COMPLAINT ((B)(4)) IS BEING CANCELLED AS IT WAS CREATED IN ERROR AS IT IS DUPLICATE TO COMPLAINT # (B)(4). THE INCIDENT WAS DETERMINED TO BE A DUPLICATE REPORT TO COMPLAINT (B)(4) (AUTHORITY MFG REPORT NUMBER (2249723-2025-0001139). AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE. REVERT ALL SECTIONS TO BLANK: B. ADVERSE EVENT OR PRODUCT PROBLEM, D. SUSPECT MEDICAL DEVICE, E. INITIAL REPORTER, G. ALL MANUFACTURERS, AND H. DEVICE MANUFACTURERS ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT ALARMED WHEN THEY TURNED IT ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203616 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