BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22156982 · Received June 6, 2025

    Report

    Report Number
    2249723-2025-0002502
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 26, 2025
    Report Date
    September 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DUE TO CHARACTERIZATION LIMIT E1 (EVENT SITE FULL NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, D5, D9, D10, E1 (INITIAL REPORTER, EVENT SITE EMAIL), E2, E3, E4, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6(HEALTH EFFECT ¿ CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, HEALTH EFFECT ¿ IMPACT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO REPRODUCE THE REPORTED MALFUNCTION. THE FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162) AND THE ALARM DAUGHTERBOARD PCBA (0670-00-0860). AN INSPECTION WAS COMPLETED AND THE UNIT WAS READY FOR USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 27 JUNE 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6) SWEMCO PART NUMBER 0670-00-0860 PCBA, ALARM DAUGHTER BOARD SERIAL NUMBER (B)(6) SWEMCO THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF: THE ALARM GOES OFF WHEN THE POWER IS OFF. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED THE PARTS INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PARTS TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL THE FAT DEPT. COULD NOT DUPLICATE THE COMPLAINT OF THE ALARM GOING OFF WHEN THE POWER IS TURNED OFF. THE PARTS PASSED TESTING. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE THE MOST PROBABLE ROOT CAUSE FOR THE POWER MANAGEMENT BOARD IS COMPONENT RELIABILITY. THE MOST PROBABLE ROOT CAUSE FOR THE ALARM DAUGHTERBOARD PCB IS COMPONENT RELIABILITY / EXCESSIVE STRESS OR FATIGUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ALARM SOUND WHEN THE POWER IS OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ALARM WAS OCCURRING FREQUENTLY WHEN THE POWER WAS OFF. THE ALARM STOPPED WHEN THE AC AND BATTERY WERE REMOVED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392442 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