BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 21430432 · Received February 21, 2025

    Report

    Report Number
    3001421318-2025-00325
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 11, 2025
    Report Date
    August 18, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS COMES TO THE FOLLOWING CONCLUSION: ADDITIONAL "INFORMATION": ON (B)(6) 2025, THE HOSPITAL REPORTED THAT THE EXPIRATORY VALVE OF THE VENTILATOR DID NOT FUNCTION AS EXPECTED DURING VENTILATION. THE DEVICE ALARMED WITH THE ASSOCIATED TECHNICAL EVENT (TE) ALARM, TE 231032 ¿ TAGD_EXPIRATION VALVE DISCONNECTED, WHICH WAS CONFIRMED IN THE EVENT LOGS AT THE STATED DATE AND TIME. MULTIPLE PRIOR OCCURRENCES OF THIS ALARM WERE ALSO DOCUMENTED IN (B)(6) AND (B)(6) 2025. THE CLINICAL STAFF REPLACE THE VENTILATOR AS A PRECAUTIONARY MEASURE TO ENSURE UNINTERRUPTED RESPIRATORY SUPPORT FOR A NEONATAL PATIENT. NO TRANSITION TO AN AMBIENT MODE WAS RECORDED FOLLOWING THE EVENT. THERE WAS NO REPORTED HARM TO THE PATIENT. DURING THE TECHNICAL INVESTIGATION CONDUCTED BY HAMILTON MEDICAL, IT WAS FOUND THAT THE MAINBOARD FAILED TO REGULATE THE VOLTAGE SUPPLIED TO THE EXPIRATORY VALVE, WHICH LED TO THE MENTIONED TECHNICAL EVENT TE 231032. AS PART OF THE SERVICE ACTIONS, THE EXPIRATORY VALVE ASSEMBLY WAS REPLACED, FOLLOWED MAINBOARD REPLACEMENTS AND A POWER SUPPLY EXCHANGE DUE TO VOLTAGE READINGS OUTSIDE SPECIFICATION ON BOTH MAIN BOARD AND POWER SUPPLY. THE VENTILATOR WAS RETURNED TO CLINICAL USE ON (B)(6) 2025. NO EVENT HAS BEEN REPORTED SINCE. CORRECTION/ADDITIONAL INFORMATION: UPDATE OF THE IMDRF CODES IN H6.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "TECHNICAL EVENT 231032 (EXPIRATION VALVE DISCONNECTED). EXPIRATORY VALVE DID NOT WORK PROPERLY." HEALTH IMPACT: ADDITIONAL DEVICE WAS REQUIRED. NO HEALTH FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692666 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown