BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 23386845 · Received October 25, 2025

    Report

    Report Number
    2249723-2025-0004426
    Event Type
    Malfunction
    Date Received
    October 25, 2025
    Date of Event
    October 4, 2025
    Report Date
    February 23, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2,H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT WHEN THE UNIT IS CONNECTED TO AC POWER, AN ALARM SOUNDS, AND STOPS WHEN THE UNIT IS POWERED ON. FAULT LOG #118 WAS FOUND AND ANOTHER VISIT WOULD NEED TO BE MADE. UPON THE SECOND VISIT, THE SOLENOID DRIVER BOARD (0670-00-1161), AND POWER MANAGEMENT BOARD (0670-00-1162) WERE REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. . THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1161 AND 0670-00-1162 WITH A REPORTED UNIT FAILURE OF AN ALARM WHEN THE DEVICE IS OFF. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARDS IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PARTS TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED ON ANY PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN E1 EVENT SITE NAME IS (B)(6). 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) SUDDENLY AN ALARM SOUNDED (POWER OFF), UNEXPECTED BEEP. FAULTLOG # 118 WAS RECORDED. THE ALARM SOUNDED WHEN AC WAS CONNECTED BUT THE POWER WAS NOT ON. PATIENT WAS NOT INVOLVED. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027988 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown