BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22138552 · Received June 4, 2025

    Report

    Report Number
    2249723-2025-0002452
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 20, 2025
    Report Date
    November 4, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, FR
    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

    UPDATED FIELDS: B4, D9(DEVICE AVAILABLE FOR EVA), G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) SAID THAT HE NEED TO REPLACE THE BATTERIES DURING PREVENTIVE MAINTENANCE 2025 BUT THE QUOTATION IS STILL NOT SIGNED. DESPITE GOOD FAITH EFFORTS (GFES), NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD : B1. UPDATED FIELD : B4 , B5 , B6 , B7 , D10, E1( EVENT SITE NAME , EVENT SITE ADDRESS, EVENT SITE CITY , EVENT SITE COUNTRY ), G3 ,G2, G6 , G1 ( CONTACT PERSON ¿ MFG SITE ) ,H6 ( HEALTH EFFECT ¿ CLINICAL CODE , HEALTH EFFECT ¿ IMPACT CODES ). IN THE INITIAL MDR 2249723-2025-0002452, THE EVENT SITE STATE AND POSTAL CODE WERE SUBMITTED FOR THE USA AS THE COUNTRY OF ORIGIN. HOWEVER, THE UPDATED INFORMATION INDICATES THAT THE FAILURE OCCURRED IN FRANCE. THEREFORE, WE ARE REVERTING THOSE SECTIONS ACCORDINGLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A BATTERY MAINTENANCE REQUIRED MESSAGE ON DEVICE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A BATTERY MAINTENANCE REQUIRED MESSAGE ON DEVICE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709378 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

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