Hamilton Medical AG became aware of a malfunction with HAMILTON-C2 ventilators when used long term with neonatal patients. If an affected HAMILTON-C2 ventilator is used cumulatively for 91 days with neonatal patient without a restart of the device, the device will switch to "ambient state", resulting in an immediate stop of ventilation. During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hamilton Medical AG previously communicated this issue through FSCAs with reference CER 110972 (May 2023) and FSCA-2025-01-01 (January 2025). This updated FSN is provided with a new reference number and addresses only HAMILTON-C2 where the neonatal option is installed. Since the initiation of the first field action in May 2023, Hamilton Medical AG did not receive any new complaint related to the issue for HAMILTON-C2 devices.
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