BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 24368263 · Received February 17, 2026

    Report

    Report Number
    2249723-2026-0001295
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 25, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: H6 (TYPE OF INVESTIGATION).

    Additional Manufacturer Narrative · 0

    OTHER CONTACT PHONE NUMBER: (B)(6). DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11,D9, H6. (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND IDENTIFIED AN ISSUE WITH THE RIBBON CABLE. THE FSE REPLACED THE UPPER DISPLAY MONITOR TO LCD CABLE ASSEMBLY (D012-00-1558). AFTER REPLACEMENT, THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. THE UNIT WAS RETURNED FOR CLINICAL USE.THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 22 APR 2026.THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1558 WITH A REPORTED UNIT FAILURE OF THE SCREEN CANNOT DISPLAY NORMALLY.THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION.THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART 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. AW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MACHINE DISPLAYING RED SCREEN. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424094 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

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