Company: Hamilton.Medical
Date of Enforcement Report 8/26/2015
Class l:
PRODUCT
The G5 ventilator provides breathing support for adult, children, infant and newborn patients. The device is intended for use in hospital and other health care facilities. It may be used for transport within a hospital or health care facility.
REASON
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.
RECALLING FIRM/MANUFACTURER
Hamilton Medical., Recall initiated 4/22/2104
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