BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 21882477 · Received April 22, 2025

    Report

    Report Number
    2249723-2025-0001768
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 2, 2025
    Report Date
    November 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (RETURN TO MANUFACTURE DATE), G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162). THE FSE RE-INSTALLED SOFTWARE. THE UNIT WAS FUNCTIONALLY CHECKED ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF BATTERY ALARM WHEN CHARGING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. WHEN THE FAT DEPT. APPLIED AC POWER TO THE CONSOLE, THE CONSOLE TURNED ON WITHOUT PRESSING THE ON/OFF SWITCH AND THE UNIT ALARMED. ON BATTERY POWER THE UNIT FUNCTIONED NORMALLY. THE BOARD FAILED TESTING. SENDING THE BOARD TO THE SUPPLIER PER PROCEDURE NUMBER (B)(4). THE FOLLOWING WAS SUBMITTED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 28 AUGUST 2025. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART. PLEASE SEE ATTACHMENT. THEY STATED THE PART HAS A DEFECTIVE U6. ROOT CAUSE FOR THIS PART IS THE U6 COMPONENT. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4). ROOT CAUSE ¿ 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER BEFORE USE THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY ALARMED WHILE CHARGING. NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015475 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown