BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23433489 · Received October 31, 2025

    Report

    Report Number
    2249723-2025-0004485
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 23, 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

    DUE TO CHARACTER RESTRICTION IN BLOCK E1. E1 EVENT SITE ADDRESS IS (B)(6). UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. CORRECTED FIELD: E1 (EVENT SITE ADDRESS). THE FSE REPLACED THE BROKEN OPTICAL SENSOR (0012-00-1562) AND PERFORMED FUNCTIONAL AND SAFETY TEST. ALL TEST PASSED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0012-00-1562 REV D, SN: (B)(6). FO SENSOR EXTENSION THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿CONNECTOR BROKEN.¿ THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND THE PART WAS FOUND BROKEN CONNECTOR. PLEASE SEE ATTACHED PICTURE. THE FAT DEPT, VERIFIED THE FAILURE MESSAGE OF ¿CONNECTOR BROKEN.¿ RETAINING THIS PART IN THE FAT DEPT. PER PROCEDURE 0002-07-D008. ROOT CAUSE 1 (RC1): THE FIBER OPTIC ADAPTER CONNECTOR (ITEM 14) OF THE 0012-00-1562 CABLE ASSEMBLY, FO SENSOR EXTENSION IS NOT ROBUST ENOUGH TO CONSISTENTLY WITHSTAND LARGE AND/OR REPEATABLE FORCE/IMPACT THAT THE CONNECTOR MAY BE SUBJECTED TO OVER THE COURSE OF CONTINUED USE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION OF E1(EVENT SITE NAME): (B)(6). 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 BY FSE THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD OPTICAL SENSOR CONNECTION BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299489 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