BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON G5

    MDR report key: 21353233 · Received February 11, 2025

    Report

    Report Number
    3001421318-2025-00268
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    December 11, 2024
    Report Date
    September 22, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). IN SECTION D4, THE 'PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI)' FIELD REMAINS EMPTY BECAUSE THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: COMPLAINT INVESTIGATION. DESPITE REPEATED EFFORTS TO OBTAIN ADDITIONAL DETAILS, NO INFORMATION WAS PROVIDED. THE INFORMATION CURRENTLY AVAILABLE REMAINS INSUFFICIENT TO SUPPORT A MEANINGFUL INVESTIGATION. KEY IDENTIFIERS SUCH AS THE HOSPITAL NAME, UNIT SERIAL NUMBER, AND OTHER RELEVANT DATA HAVE NOT BEEN PROVIDED. FURTHERMORE, THE EVENT DESCRIPTION -¿POSSIBLE PNEUMOTHORAX AFTER APNEA TESTING ON A BRAIN DEAD PATIENT¿ - IS VAGUE AND DOES NOT CONFIRM THAT AN ACTUAL HARM OCCURRED CONSIDERING THE CURRENT CIRCUMSTANCES SURROUNDING THE EVENT, THE RELEASE OF ANY FURTHER INFORMATION IS NO LONGER ANTICIPATED. IN RESPONSE TO OUR INQUIRY, THE FOLLOWING INFORMATION HAS BEEN RECEIVED: ¿THANK YOU FOR CONTACTING THE EMDR HELPDESK REGARDING YOUR EMAIL. IF YOU WILL REVIEW THE INFORMATION PROVIDED IN THE REPORT BY THE VOLUNTARY SUBMITTER, UNDER SECTION D, QUESTION 9 OF THE FDA FORM 3500A, PRODUCT INFORMATION, IF THIS BOX IS CHECKED THEN THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. BASED ON THE INSTRUCTIONS FOR COMPLETION OF THE FDA 3500A FORM, THE REPORTER WOULD SELECT THIS BOX IN RESPONSE TO THE SUBJECT QUESTION WHEN THE DEVICE IS NOT AVAILABLE. DEVICES THAT ARE THE SUBJECT OF REPORTS SUBMITTED SHOULD NOT BE SENT TO FDA. AS SUCH, FDA DOES NOT HAVE ACCESS TO THE PRODUCT THAT IS THE SUBJECT OF THE EVENT REFERENCED IN YOUR EMAIL. THE COPY OF THE REPORT THAT WAS SENT PROVIDES ALL OF THE INFORMATION THAT THE FDA IS ALLOWED TO RELEASE ABOUT THE REPORT IN QUESTION. PLEASE BE AWARE THAT VOLUNTARY SUBMITTERS CAN REQUEST THAT THEY NOT BE IDENTIFIED TO THE DEVICE MANUFACTURER.¿ IT IS IMPORTANT TO NOTE THAT THE FDA HAS EXPLICITLY STATED IT WILL NOT RELEASE ANY FURTHER INFORMATION BEYOND WHAT HAS ALREADY BEEN PROVIDED, IN ACCORDANCE WITH THE CUSTOMER'S REQUEST TO REMAIN ANONYMOUS. AS A RESULT, THE DEVICE IS UNAVAILABLE FOR EVALUATION, AS NEITHER THE CUSTOMER'S IDENTITY NOR THE SERIAL NUMBER IS KNOWN BY THE MANUFACTURER. GIVEN THESE CONSTRAINTS¿INCLUDING THE ABSENCE OF DEVICE, THE LACK OF CLEAR EVENT DETAILS, AND THE ABSENCE OF CONFIRMED PATIENT HARM¿IT IS NOT POSSIBLE TO DETERMINE WHETHER A DEVICE MALFUNCTION OCCURRED, NOR TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED CLINICAL OUTCOME.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: QUOTATION FROM THE REPORTER: "POSSIBLE PNEUMOTHORAX AFTER APNEA TESTING ON A BRAIN DEAD PATIENT." ACCORDING TO THE INFORMATION RECEIVED, ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY; HOWEVER, THE SPECIFIC ACTIONS TAKEN HAVE NOT BEEN DISCLOSED. THE CAUSALITY OF THE SERIOUS INJURY ASSOCIATED WITH THE HAMILTON-G5 HAS NOT YET BEEN DETERMINED AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE EVENT DESCRIPTION -¿POSSIBLE PNEUMOTHORAX AFTER APNEA TESTING ON A BRAIN DEAD PATIENT¿ - IS VAGUE AND DOES NOT CONFIRM THAT AN ACTUAL HARM OCCURRED. ACCORDING TO THE INFORMATION RECEIVED, ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY; HOWEVER, THE SPECIFIC ACTIONS TAKEN HAVE NOT BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS RECEIVED. DESPITE REPEATED EFFORTS TO OBTAIN ADDITIONAL DETAILS, NO INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753627 HAMILTON G5 HAMILTON G5 CBK HAMILTON MEDICAL AG 159002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention