BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 22437073 · Received July 8, 2025

    Report

    Report Number
    2249723-2025-0002930
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 24, 2025
    Report Date
    October 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN E1, FULL EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: E1(EVENT SITE TELEPHONE). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND THE ISSUE OF UNSTABLE ARTERIAL PRESSURE WAVEFORM WAS CONFIRMED. POOR CONTACT IN THE OPTICAL SENSOR CONNECTOR WAS SUSPECTED, SO THE BLUE CONNECTOR (CBL ASSY, FO SENSOR EXT) WAS REPLACED. FIBER OPTIC TEST PWM 48 LAMP OUTPUT 182 LAMP OUTPUT/PWM 3.79 SIGNAL COUNT 126 SIGNAL LEVEL 157. AFTER REPLACEMENT, A PERFORMANCE CHECK WAS PERFORMED ACCORDING TO THE SERVICE MANUAL AND THE RESULTS WERE GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BLOOD PRESSURE WAVEFORM MALFUNCTION WHEN USING A SENSOR BALLOON. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399562 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown