Medical Device Safety and Recalls: Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure

A recall has been issued for the G5 Ventilator. The ventilator may stop working, without sounding an alarm, when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver).

This problem can occur during the following conditions:

• When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or,
• When disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other.

If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

The firm has received a total of 1 report of device malfunction.  No injuries or deaths were reported. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm471717.htm

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