BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 21959826 · Received May 5, 2025

    Report

    Report Number
    2249723-2025-0002077
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 14, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 2249723-2025-0002077 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BATTERY MAINTENANCE DUE AND ALSO REQUIRES SAFETY DISC REPLACEMENT. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423469 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