BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22573602 · Received July 23, 2025

    Report

    Report Number
    2249723-2025-0003116
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 8, 2025
    Report Date
    November 10, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, HEALTH EFFECT ¿ IMPACT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE INVESTIGATED THE BROKEN FIBER OPTIC CONNECTION PORT (0012-00-1562). THE FSE WAS ABLE TO REPRODUCE THE CUSTOMER¿S STATED ISSUE. THE FSE REPLACED BROKEN PORT. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS. UNIT CLEARED FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0012-00-1562 WITH A REPORTED UNIT FAILURE OF A BROKEN FIBER OPTIC CONNECTION PORT. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A DAMAGED FIBER OPTIC PORT. SEE ATTACHMENT. FAILURE IS CONFIRMED WITH THE MOST PROBABLE ROOT CAUSE BEING A USER OPERATIONAL CONTEXT. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: H6 MEDICAL DEVICE ¿ PROBLEM CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CHECK OUT OF A WORK ORDER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP'S (IABP) FIBER OPTIC CONNECTION PORT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE CARDIOSAVE INTRA AORTIC BALLOON PUMP, THE FIBER OPTIC CONNECTION PORT WAS BROKEN, THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036213 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