BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 24774965 · Received April 3, 2026

    Report

    Report Number
    2249723-2026-0002026
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 22, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, E3, E2, G2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND DETERMINED THAT THE ISSUE WAS RELATED TO EXPIRED SAFETY DISK (0202-00-0140) AND TIDAL VOLUME DISK (0202-00-0142). THE SAFETY DISK (0202-00-0140) AND TIDAL VOLUME DISK (0202-00-0142) WERE REPLACED, AFTER WHICH THE UNIT UNDERWENT FUNCTIONAL TESTING AND PASSED ALL PERFORMANCE CHECKS ACCORDING TO THE SERVICE MANUAL. THE DEVICE WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A DAILY CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838462 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown