BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22700628 · Received August 4, 2025

    Report

    Report Number
    2249723-2025-0003364
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 31, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD : B4 , G3 , G6 , H2 , H11. CORRECTED FIELD : D9 , H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT, BUT WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. THE FSE IDENTIFIED THAT THE FIBER-OPTIC CONNECTOR WAS DAMAGED, BUT FUNCTIONED AS INTENDED. THE FSE REPLACED THE FIBER-OPTIC SENSOR EXTENSION ASSEMBLY (0012-00-1562). THE EQUIPMENT WAS TESTED. THE FSE VERIFIED THAT IT WAS FUNCTIONAL AND WITHIN SPECIFICATIONS. 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 0012-00-1562 WITH A REPORTED UNIT FAILURE OF A BROKEN FIBER OPTIC CONNECTOR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE DAMAGED BE THERE FIBER OPTIC CABLE PLUGS IN TO. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4) REV. AU. THE MOST PROBABLE ROOT CAUSE IS EXCESSIVE STRESS OR FATIGUE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D8, D9, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT, BUT WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. THE FSE IDENTIFIED THAT THE FIBER-OPTIC CONNECTOR WAS DAMAGED, BUT FUNCTIONED AS INTENDED. THE FSE REPLACED THE FIBER-OPTIC SENSOR EXTENSION ASSEMBLY (0012-00-1562). THE EQUIPMENT WAS TESTED. THE FSE VERIFIED THAT IT WAS FUNCTIONAL AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ¿HAD RECEIVED AN ERROR MESSAGE, AND CHANGED OUT THE PUMP CONSOLE. ONCE SWITCHED IT OUT, THE ERROR MESSAGE WENT AWAY.¿ CUSTOMER REPORTED THE MESSAGES WERE ¿UNABLE TO UPDATE TIMING¿ AND ¿NO TRIGGER¿. I REVIEWED THE NATURE OF BOTH MESSAGES WITH CUSTOMER. AFTER CUSTOMER STATED THAT THE FIRST CARDIOSAVE PUMP SHOULD BE SERVICED AND PLANNED TO SEND THE PUMP TO BIOMED. CUSTOMER REPORTED NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205105 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female