BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24256966 · Received February 4, 2026

    Report

    Report Number
    2249723-2026-0001080
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 23, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION CONCLUSIONS). FULL INITIAL REP NAME: (B)(6). THE FSE THAT ENCOUNTERED THE ISSUE FOUND FAULT # 139 IN THE LOGS. THERE WAS NO ISSUE FOUND WITH THE PROCESSOR BOARD OR CONNECTIONS. THE FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162). THE PM WAS COMPLETED WITH CALIBRATION, SAFETY, AND FUNCTIONALITY CHECKS. THE IABP WAS RETURNED TO THE CUSTOMER.THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: (B)(4) 26 MAR 2026.THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 WITH A REPORTED UNIT FAILURE OF A SHUTDOWN DURING INSPECTION.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 FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4). CAPA 539589 ROOT CAUSE: SERIAL DATA FROM THE POWER MANAGEMENT BOARD IS SENT WHILE THE EXECUTIVE BOARD IS STILL POWERING UP. MOST OF THE TIME THE EXECUTIVE BOARD CAN DEAL WITH THE EXCESS SERIAL DATA WITHOUT INCIDENT. HOWEVER, IN THE FAILURE CASE THE EXECUTIVE BOARD THROWS AN ERROR THAT IS NOT HANDLED CORRECTLY AND CAUSES THE UNIT TO GO INTO SYSTEM FAILURE. CAPA 566812 ROOT CAUSE 1 ¿ THERE IS NO SURGE PROTECTION IN THE INTERFACE BETWEEN THE CHARGING CIRCUITRY AND THE BATTERIES INSTALLED IN THE POWER SLOTS OF THE UNIT.ROOT CAUSE 2 ¿ THE TANTALUM CAPACITORS USED ON THE FOLLOWING TWO (2) PCBAS ARE NOT WITHIN THE CAPACITOR MANUFACTURER¿S (VISHAY) DE-RATING GUIDELINES WHICH MAY RESULT IN CAPACITOR FAILURE CAUSING AN OVERCURRENT CONDITION ON THE VBULK POWER SUPPLY WHICH DAMAGES THE POWER MANAGEMENT BOARD.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT: E1(INITIAL REPORTER)- (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT OFF AFTER POWER UP.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP), HYBRID TYPE B PLUG, HAD A SUSPECTED DEFECTIVE POWER MANAGEMENT BOARD. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319493 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 N/A.