FDA-Device2024-06-26Class I
Ventilator HAMILTON-C6, PN: 160021
Hamilton Medical AG
Hazard
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
Sold states
US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
Affected count
68
Manufactured in
Via Crusch 8, N/A, Bonaduz, N/A, Switzerland
Products
Ventilator HAMILTON-C6, PN: 160021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2024Don't want to check this manually?
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