BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 21490881 · Received February 28, 2025

    Report

    Report Number
    2249723-2025-0000945
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Report Date
    July 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELS: B5. UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY A QUOTE REQUEST. THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000945 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) QUOTE FOR 2 NUMBERS OF BATTERIES. PATIENT NOT INVOLVED.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY A QUOTE REQUEST. THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000945 IN YOUR DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665480 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown