BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21394878 · Received February 18, 2025

    Report

    Report Number
    2249723-2025-0000735
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 29, 2025
    Report Date
    November 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, E1 (EVENT SITE EMAIL).

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, E1 (INITIAL REPORTER NAME), E3, H11 (TYPE OF INVESTIGATION, HEALTH EFFECT ¿ CLINICAL CODE, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE FIBER-OPTIC ASSEMBLY (0997-00-1169). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS TO FACTORY SPECIFICATIONS. THE IABP WAS CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0997-00-1169 WITH A REPORTED UNIT FAILURE OF A FIBER OPTIC ERROR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART 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. FAILS THE FIBER OPTIC TEST DUE TO A FIBER OPTIC SENSOR ERROR. SEPARATING THE ASSEMBLY INTO TWO PARTS. SENDING PN: 0992-00-1017, SN: (B)(6), FISO AND PN: 0670-00-1160, SN: (B)(6), SWEMCO TO THE RESPECTIVE SUPPLIER PER PROCEDURE NUMBER: 0002-07-D008 REV. AT. THE FOLLOWING WAS SUBMITTED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART 0670-00-1160. THEY STATED THE PART PASSED TESTING. ROOT CAUSE FOR THIS PART IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU. THE FOLLOWING WAS SUBMITTED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNEV FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART 0992-00-1017 SN: (B)(6), FISO. THEY STATED THE PART FAILED TESTING BUT NO ROOT CAUSE WAS IDENTIFIED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    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 BEFORE USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ENCOUNTERED FIBER OPTIC ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183419 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