Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State
The Hamilton-G5 is intended for use by health care providers to provide breathing support for adult, pediatric, infant and neonatal patients. This device is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate transport within a hospital or hospital type facility.
Reason for Recall: Hamilton Medical AG is recalling Hamilton-G5 Ventilators due to the potential for “Panel connection lost” error message resulting in the ventilator to stop working and enter an ambient state. When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator sounds a high priority alarm with visual blinking LEDs alerting medical staff. When the ventilator enters the ambient state, alternative ventilation must be provided immediately. Hamilton Medical AG has received 14 complaints associated with the error message, however no patient injury or death have been reported due to the issue.
Hamilton Medical AG had developed a new software for the Hamilton-G5 ventilators. The software version 2.80 reduces the likelihood of the ventilator entering an ambient state due to the occurrence of an error leading to a “panel connection lost” error message.
Use of the affected device, without the new software, may lead to risk of immediate or long-term consequences to a patient that may result in irreversible harm, injury, or death.
For more information visit: https://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-ag-recalls-hamilton-g5-ventilators-due-potential-sporadic-error-message-resulting?utm_campaign=2019-07-12%20Recall%20Hamilton%20G5%20Ventilator&utm_medium=email&utm_source=Eloqua
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