BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHILLER AG

    MDR report key: 24566537 · Received March 11, 2026

    Report

    Report Number
    8030978-2026-91337
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Report Date
    March 11, 2026
    Manufacturer
    SCHILLER AG
    Product Code
    MHX
    UDI-DI
    07613365000085
    PMA / PMN Number
    K012226
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: MERGE HEMODYNAMIC SYSTEM NOT WORKING AS DESIGNED, UNABLE TO WORK IN CATH LAB ROOM #4. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: EXTRACTION OF DUAL-CHAMBER PACEMAKER, LEFT HEART CATHETERIZATION AND RIGHT HEART CATHETERIZATION. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN. ADDITIONAL INFORMATION FOR PATIENT #1: OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: N/A. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: HEPATIC/RENAL DYSFUNCTION; OTHER; CORONARY HEART DISEASE. OTHER CHARACTERISTICS OR MEDICAL CONDITIONS: AORTIC STENOSIS, ATRIAL FIBRILLATION, SEVERE MITRAL VALVE REGURGITATION, CKD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629039 SCHILLER AG ARGUS PB-1000 MHX SCHILLER AG 07613365000085

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male