BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23475239 · Received November 5, 2025

    Report

    Report Number
    2249723-2025-0004566
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    January 20, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11 CORRECTED FIELD : G2 A GETINGE FIELD SERVICE ENGINEER FSE EVALUATED THE UNIT, REPLACED THE FO CABLE, AND PERFORMED TESTING. ALL FUNCTIONAL AND SAFETY CHECKS REQUIRED TO MEET FACTORY SPECIFICATIONS WERE PERFORMED AND PASSED. FURTHERMORE, THE NVRAM IC AND EXTERNAL BATTERIES WERE REPLACED AT THE PRESCRIBED INTERVALS PER THE SERVICE MANUAL. THE BATTERIES WERE NOT EXPIRED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THIS PART WITH A REPORTED UNIT FAILURE OF A BROKEN FIBER OPTIC CONNECTOR FOUND DURING PM. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE PART RECEIVED, FIBER OPTIC SENSOR EXTENSION CABLE ASSEMBLY, SERIAL NUMBER (B)(6), AND FOUND THAT THE BLUE RECEPTACLE HOUSING OF THE FIBER OPTIC CONNECTOR WAS BROKEN. DUE TO THE EXTENT OF THE DAMAGE, FURTHER INVESTIGATION BY THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS NOT POSSIBLE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS ABLE TO VERIFY THE FAILURE AS DESCRIBED BY THE CUSTOMER. THE PART IS BEING RETAINED IN THE FAT DEPARTMENT. THE PROBABLE ROOT CAUSE PER CAPA 792593 IS THAT THE FIBER OPTIC ADAPTER CONNECTOR OF THE CABLE ASSEMBLY FO SENSOR EXTENSION IS NOT ROBUST ENOUGH TO CONSISTENTLY WITHSTAND LARGE OR REPEATABLE FORCE OR IMPACT THAT THE CONNECTOR MAY BE SUBJECTED TO DURING CONTINUED USE.

    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 DURING PREVENTIVE MAINTENANCE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BROKEN FINER OPTIC CONNECTOR. THERE WAS NO PATIENT INVOLVED AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319875 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 N/A.