BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 21156929 · Received January 15, 2025

    Report

    Report Number
    2249723-2025-0000218
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 27, 2024
    Report Date
    April 5, 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, B5, D9, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (HEALTH EFFECT ¿ CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS ), H11 CORRECTED FIELDS: E3 A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY REPLACED THE TOP LCD, UPPER DISPLAY MONITOR BOARD, UPPER DISPLAY MONITOR CABLE, UPPER MONITOR CABLE . THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 , E1 EVENT SITE FULL NAME IS (B)(6) HOSPITAL. E1 EVENT SITE ADDRESS FULL ADDRESS IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD - H6(COMPONENT CODES). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY REPLACED THE TOP LCD (D160-00-0127), UPPER DISPLAY MONITOR BOARD (D670-00-00-1183), UPPER DISPLAY MONITOR CABLE (D012-00-1817), UPPER MONITOR CABLE (0012-00-1845) . THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. (B)(6) 2025 THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 23 MAR 2026. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: (B)(4). PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE UPPER DISPLAY BEING DISTORTED. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PARTS 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. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AV. AS THERE WAS NO PART FAILURE CONFIRMED, THE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A DISTORTED UPPER DISPLAY. THE UNIT WAS REPLACED WITH A SUBSTITUTE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S UPPER DISPLAY WAS DISTORTED. THERE WAS NO IMPACT ON PATIENTS OR TREATMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448972 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