BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19927063 · Received August 7, 2024

    Report

    Report Number
    2249723-2024-03192
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 17, 2024
    Report Date
    May 2, 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

    UPDATED FIELD- B4, B5, D8, D9, G3, G6, H2, H3 , H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, HEALTH EFFECT ¿ IMPACT CODES, COMPONENT CODES , INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED DISPLAY BRACKET FRAME (0406-00-0910) UPPER BRACKET FRAME (0406-00-0894), DISPLAY LEFT HINGE (0105-00-0138-01), RIGHT DISPLAY HINGE (0105-00-0138-02), UPPER HINGE COVER (0380-00-0561) AND SAFETY DISK DRIVE SIDE (0202-00-0140) AS IT EXCEEDED 6,000,000 CYCLES. INSPECTION WAS PERFORMED BASED ON THE SERVICE MANUAL AND THE RESULT WERE GOOD.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WHEN THE BED WAS MOVED UNIT WAS HIT AND DAMAGED BY CUSTOMER. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE BY PATIENT, WHEN THE BED WAS MOVED, THE DISPLAY OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS HIT AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265457 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