BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON 3.0 TMS THERAPY SYSTEM

    MDR report key: 21303356 · Received February 4, 2025

    Report

    Report Number
    8021774-2025-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Report Date
    February 4, 2025
    Manufacturer
    THE MAGSTIM COMPANY LTD
    Product Code
    OBP
    PMA / PMN Number
    K232235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    5800-00 - HORIZON 3.0 MAINFRAME DEVICES WERE IDENTIFIED AS INCORRECTLY MARKED WITH (B)(6) THAT HAVE SHIPPED TO NON-EU MARKETS. HORIZON 3.0 SYSTEMS HAVE NOT BEEN APPROVED UNDER EU MDD/EU MDR YET SO SHOULD NOT BEAR A CE MARK. AN INTERNAL CAPA (346) WAS RAISED DUE TO BSI'S IP AND OWNERSHIP OF THE NOTIFIED BODY NUMBER. A QUANTITY OF (B)(4) ITEMS ARE AFFECTED IN THE FIELD. US: (B)(6) ,(B)(4) UNITS WERE SHIPPED WITH A CE MARK (NO CE MARK OVER LABEL USED TO OCCLUDE THIS). THE ARE NO ASSOCIATED USER OR PATIENT HAZARDS OR RISKS TO SAFETY AND THE PERFORMANCE OF THE AFFECTED DEVICES. THIS ISSUE IS A LABELLING ERROR ONLY AND DOES NOT AFFECT THE FUNDAMENTAL FUNCTIONALITY OR OPERATION OF THE DEVICE. IT DOES NOT ALTER ITS INTENDED PURPOSE OR COMPROMISE ITS PERFORMANCE IN ANY WAY. THE DEVICE CONTINUES TO OPERATE AS DESIGNED AND INTENDED BY THE MANUFACTURER. THIS LABELLING ERROR DOES NOT INTRODUCE ANY NEW SAFETY RISKS TO THE END USER. THE DEVICE'S DESIGN, CONSTRUCTION, AND SAFETY FEATURES, WHICH ARE CRITICAL FOR USER SAFETY, REMAIN UNAFFECTED BY THE INCLUSION OF A CE MARK. BUILD ERROR DETERMINED AS A ROOT CAUSE. BOTH THE 5800-00 (NOT CE) AND 4950-00 (CE) USE THE SAME REAR PLATE LABEL (AS PER THE 5846-01 BOTTOM COVER ASSEMBLY) AND THE OPERATOR DID NOT COVER UP THE CE MARKING AS PER INSTRUCTION. THE OPERATOR HAD BUILT BOTH TYPES OF PRODUCTS WITHIN A SHORT TIME PERIOD AND IS LIKELY TO HAVE OMITTED THE CE COVER LABEL FOR THE 5800-00. AGREED ACTION TO SEND LABELS TO AFFECT US CUSTOMERS TO ALLOW FOR APPLICATION TO THE COMPONENT.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED IN ERROR, NO ADVERSE EVENT OCCURRED. THIS SHOULD BE CONSIDERED AS A CORRECTION AND IS CLASS III WHEREBY ONLY RECORD KEEPING REQUIREMENTS APPLY AND NO REPORTING VIA WAS REQUIRED VIA THE ESG. THERE ARE NO ASSOCIATED USER OR PATIENT HAZARDS OR RISKS TO SAFETY AND THE PERFORMANCE OF THE AFFECTED DEVICES. FIELD SAFETY NOTICES AND LABELS HAVE BEEN SENT TO THE AFFECTED CUSTOMERS TO OCCLUDE THE CE MARKING WHICH WAS INCORRECTLY PRESENT ON THE DEVICES. AN MDR DELETION REQUEST WAS SENT TO THE MDR TEAM VIA EMAIL AS ATTACHED AND THE RECOMMENDED STEPS HAVE BEEN TAKEN TO UPDATE THIS REPORT. MDR TEAM RESPONSE: WE REVIEWED YOUR REQUEST FOR DELETION AND FOUND THAT THAT THE SUBMISSION 8021774-2025-00001 CANNOT BE DELETED FROM OUR SYSTEM BASED ON THE REASON PROVIDED. IN SUCH CASES, A FOLLOW-UP REPORT CAN BE USED TO CORRECT MOST ERRORS IN YOUR SUBMISSION, EXCEPT THE REPORT NUMBER, WHICH IS USED TO LINK INITIAL AND FOLLOW-UP REPORTS. PLEASE SEND A FOLLOW-UP REPORT (ALSO KNOWN AS SUPPLEMENTAL REPORT) TO PROVIDE ADDITIONAL INFORMATION ABOUT YOUR INITIAL SUBMISSION. YOU MAY INCLUDE A STATEMENT IN H11 EXPLAINING WHY THE REPORT WAS SUBMITTED IN ERROR. YOUR FOLLOW-UP REPORT HAS THE SAME REPORT NUMBER AS THE INITIAL, BUT YOU WILL MARK IT AS A "FOLLOW-UP" AND PROVIDE A FOLLOW-UP NUMBER (STARTING WITH 1) IN G6.

    Description of Event or Problem · 0

    (B)(6) X 5800-00 HORIZON 3.0 MAINFRAMES WERE SHIPPED INTO THE US WITH A CE MARK. THESE DEVICES HAVE NOT BEEN APPROVED UNDER EU MDD/EU MDR YET SO SHOULD NOT BEAR A CE MARK. BSI IS THE NOTIFIED BODY FOR THE MAGSTIM COMPANY LIMITED, (B)(6) IS OWNED BY AND IS INTELLECTUAL PROPERTY OF THE BSI GROUP. SINCE THIS PRODUCT HAS NOT YET RECEIVED CLEARANCE FOR SALE IN THE EU, THE CE MARK SHOULD NOT BE PRESENT ON THESE DEVICES. THE ARE NO ASSOCIATED USER OR PATIENT HAZARDS OR RISKS TO SAFETY AND THE PERFORMANCE OF THE AFFECTED DEVICES. THIS ISSUE IS A LABELLING ERROR ONLY AND DOES NOT AFFECT THE FUNDAMENTAL FUNCTIONALITY OR OPERATION OF THE DEVICE. IT DOES NOT ALTER ITS INTENDED PURPOSE OR COMPROMISE ITS PERFORMANCE IN ANY WAY. THE DEVICE CONTINUES TO OPERATE AS DESIGNED AND INTENDED BY THE MANUFACTURER. THIS LABELLING ERROR DOES NOT INTRODUCE ANY NEW SAFETY RISKS TO THE END USER. THE DEVICE'S DESIGN, CONSTRUCTION, AND SAFETY FEATURES, WHICH ARE CRITICAL FOR USER SAFETY, REMAIN UNAFFECTED BY THE INCLUSION OF A CE MARK.

    Description of Event or Problem · 0

    27 X 5800-00 HORIZON 3.0 MAINFRAMES WERE SHIPPED INTO THE US WITH A CE MARK. THESE DEVICES HAVE NOT BEEN APPROVED UNDER EU MDD/EU MDR YET SO SHOULD NOT BEAR A CE MARK. BSI IS THE NOTIFIED BODY FOR THE MAGSTIM COMPANY LIMITED, CE 2797 IS OWNED BY AND IS INTELLECTUAL PROPERTY OF THE BSI GROUP. SINCE THIS PRODUCT HAS NOT YET RECEIVED CLEARANCE FOR SALE IN THE EU, THE CE MARK SHOULD NOT BE PRESENT ON THESE DEVICES. THE ARE NO ASSOCIATED USER OR PATIENT HAZARDS OR RISKS TO SAFETY AND THE PERFORMANCE OF THE AFFECTED DEVICES. THIS ISSUE IS A LABELLING ERROR ONLY AND DOES NOT AFFECT THE FUNDAMENTAL FUNCTIONALITY OR OPERATION OF THE DEVICE. IT DOES NOT ALTER ITS INTENDED PURPOSE OR COMPROMISE ITS PERFORMANCE IN ANY WAY. THE DEVICE CONTINUES TO OPERATE AS DESIGNED AND INTENDED BY THE MANUFACTURER. THIS LABELLING ERROR DOES NOT INTRODUCE ANY NEW SAFETY RISKS TO THE END USER. THE DEVICE'S DESIGN, CONSTRUCTION, AND SAFETY FEATURES, WHICH ARE CRITICAL FOR USER SAFETY, REMAIN UNAFFECTED BY THE INCLUSION OF A CE MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61966 HORIZON 3.0 TMS THERAPY SYSTEM HORIZON 3.0 MAINFRAME OBP THE MAGSTIM COMPANY LTD 5800-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other