BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22112712 · Received May 30, 2025

    Report

    Report Number
    2249723-2025-0002407
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 16, 2025
    Report Date
    August 29, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0002445. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0002445 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0002407 IN YOUR DATABASE."

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BATTERY CHARING PROBLEM AND UNEXPECTED SHUTDOWN WITH BEEPING SOUND. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578990 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

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