BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22344348 · Received June 27, 2025

    Report

    Report Number
    2249723-2025-0002751
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 13, 2025
    Report Date
    January 19, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11, G1 ( CONTACT PERSON ¿ MFG SITE ). CORRECTED FIELD : B5. A GETINGE FIELD SERVICE ENGINEER (FSE) VERIFIED IT WAS A GROUND ISSUE. UPPER PANEL GROUND SPONGE ON THE PIM ASSEMBLY WAS WORN (FLAT) CAUSING GROUND CONTACT WITH THE CHASSIS, WHEN THIS HAPPENS THE EXTERNAL PHONO JACK INPUTS WILL NOT WORK. UPPER PANEL GROUND SPONGE WAS NOT MAKING CONTACT TO BOTH PORTS. FSE REPLACED UPPER PANEL ASSEMBLY (D997-00-0644). THE TIDAL VOLUME DISK (D202-00-0142) WAS ALSO REPLACED AS IT WAS EXPIRED, EXTERNAL ECG AND B/P PORTS POPULATED VITALS ON SCREEN. ISSUE RESOLVED. PERFORMED ALL TRANSDUCER CALIBRATIONS 60MIN BATTERY RUN TIME @120BPM. TOUCHSCREEN TEST ¿PASS¿. READY FOR PATIENT CARE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY ANGEL RODRIGUEZ, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 11 JULY 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0644 WITH A REPORTED UNIT FAILURE OF THE GROUND SPONGE CAUSING ISSUES TO THE PORTS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A WORN GROUND SPONGE. SEE ATTACHMENT. THIS COULD POSSIBLY CAUSE AN ISSUE WITH THE PORTS. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU. THE TIDAL VOLUME DISK WAS REPLACED AS IT WAS EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY FIELD SERVICE TECHNICIAN( FST) THAT, DURING PREVENTIVE MAINTENANCE (PM), THE EXTERNAL ECG AND B/P PORTS OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT FUNCTIONING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY FIELD SERVICE TECHNICIAN(FST) THAT, DURING PREVENTIVE MAINTENANCE (PM), THE EXTERNAL ECG AND B/P PORTS OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT FUNCTIONING.THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973918 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