BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23665256 · Received November 27, 2025

    Report

    Report Number
    2249723-2025-0004855
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Report Date
    January 3, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11 , E1 ( EVENT SITE EMAIL ). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING THE POWER MANAGEMENT BOARD (0670-00-1162) FUNCTIONAL TESTED WITHOUT ANY FAILURES. ALL WORK WAS PERFORMED ON THE MAINTENANCE SO# (B)(4). CARDIOSAVE IABP SERVICES COMPLETED. SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 WITH A REPORTED UNIT FAILURE OF A FAULT CODE 139 FOUND DURING ANNUAL MAINTENANCE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD 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 FAULT CODES OR FAILURES CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SEMI-ANNUAL MAINTENANCE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FOUND FAULT CODE 139 5 TIMES IN THE LOGS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3445 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown