Hamilton Medical AG: Ventilator HAMILTON-C6, PN: 160021

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA. Quantity: 68 Lot/code info: UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6

UPC codes

07630002808590

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.