BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 23592437 · Received November 19, 2025

    Report

    Report Number
    2249723-2025-0004746
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 6, 2025
    Report Date
    January 19, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD : B4 , G3 , G6 , H2 , H11 CORRECTED FIELD : H6 ( MEDICAL DEVICE ¿ PROBLEM CODE ).

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, G3, G6, H2, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11 A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE UNIT. UPON ARRIVAL, FSE CHECKED THE UNIT, CONFIRMED THAT CATHETER EXTENSION INPUT PORT CONNECTOR IS BROKEN AND THE PROTECTIVE EARTH RESISTANCE FROM THE LINE CORD WAS INFINITE. THE LINE CORD ISSUE WAS DISCOVERED DURING THE REPAIR. THE FSE REPLACED PNEUMATIC INTERFACE MODULE, ROHS AND REEL, AC POWER CORD, CEE 7/7 "TYPE E/F". THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY TESTS. BASED ON THE EVALUATION RESULTS PROVIDED BY THE FIELD SERVICE ENGINEER, THE FAILURE OCCURRED DUE TO A DEFECTIVE ¿PNEUMATIC INTERFACE MODULE, ROHS AND REEL, AC POWER CORD, CEE 7/7 "TYPE E/F". THE ISSUE WAS RESOLVED BY REPLACING THE MALFUNCTIONING PART. HOWEVER, ROOT CAUSE EVALUATION FOR THE REPLACED PART CANNOT BE PERFORMED SINCE THE DEFECTIVE PARTS ARE NOT SHIPPED YET.

    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

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), IAB CATHETER CONNECTION TO THE PATIENT INTERFACE MODULE BROKEN AND THE PROTECTIVE EARTH RESISTANCE WAS INFINITE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65148 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.