BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19840991 · Received July 26, 2024

    Report

    Report Number
    2249723-2024-02994
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 8, 2024
    Report Date
    May 29, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 SITE NAME: (B)(6) HOSPITAL.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE FSE REPLACED THE MOTOR CONTROL BOARD, POWER MANAGEMENT BOARD, BACKPLANE BOARD AND SOLENOID CONTROL BOARD TO RESOLVE THE ISSUE BUT THE HOSPITAL IS REFUSING TO ACCEPT THE DEVICE UNTIL MEASURES ARE TAKEN TO ADDRESS THE SOLENOID DRIVER BOARD AND POWER MANAGEMENT BOARD. IF INFORMATION IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND UPDATED. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-1162 REV. J, PN: 0670-00-1159 REV. B, PN: 0670-00-1163 REV. D, PN: 0670-00-1161 REV. B. PARTS WERE RECEIVED WITH A REPORTED FAILURE OF A SHUTDOWN WHILE IN USE ON A PATIENT. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND PN: 0670-00-1159 HAS SMOKE DAMAGE. PN: 0670-00-1161 HAS BLOWN COMPONENTS. ROOT CAUSE FOR THESE TWO PARTS IS IMPOSSIBLE TO DEFINE. THE OTHER PARTS WERE IN GOOD CONDITION. THE FAT INSTALLED PN: 0670-00-1162 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. THE UNIT POWERS UP AUTOMATICALLY INDICATING A FAULT ON THIS PART. THE FAT INSTALLED PN: 0670-00-1163 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 ISSUES FOUND. SENDING PN: 0670-00-1162 TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE NUMBER: 0002-07-D008 REV. AS. RETAINING THE OTHER PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AS. THE FOLLOWING WAS SUBMITTED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 31 MAR 2025. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART. THEY STATED: "1. PERFORM VISUAL CHECK RESULT: NO ABNORMALITY FOUND 2. BOARD WAS RE-TESTED AT FCT RESULT: FAILED STEP 8.9.6.1 BCP, AC/BULK, (DCIN/BAT) (PATHENABLE) AT TP73 & 8.9.8 BCP, AC/BULK, (DCIN/BAT) (PATHENABLE) AT TP59 3. PERFORM TROUBLESHOOTING ON THE BOARD - FOUND Q31, Q33, Q35 DEFECTIVE" ROOT CAUSE FOR THIS PART IS FAULTY Q31, Q33, AND Q35. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AT. THE PROBABLE ROOT CAUSE FOR THE POWER MANAGEMENT BOARD IS THAT THERE IS NO SURGE PROTECTION IN THE INTERFACE BETWEEN THE CHARGING CIRCUITRY AND THE BATTERIES INSTALLED IN THE POWER SLOTS OF THE UNIT OR THE TANTALUM CAPACITORS USED ON THE SOLENOID CONTROL BOARD AND POWER MANAGEMENT BOARD 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE BY PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUTDOWN, THEY SMELLED SOMETHING BURNING, AND IT WAS UNABLE TO BE RESTARTED. REPLACED WITH IN-HOSPITAL CS300. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227927 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male UNKNOWN.