The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- G5 Ventilator V2.00 and V2.31
- Ventilator Catalog number: 1590001
- Software catalog numbers: Full list of software numbers.
- Distribution Dates: March 2007 to March 2014
- Devices Recalled in the U.S.: 1128 units in the U.S.
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 for Recall
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.
Who may be affected
This situation can occur in all patient groups (adult, children, infant and newborn).
What to Do
Hamilton Medical provided the following recommendations:
- After a suctioning maneuver is finished, the operator must verify that the ventilation continues.
- If the ventilation does not continue, use one of the following options to re-establish ventilation:
- Pressing the "Manual Breath" key on the ventilator's front side.
- Change of the ventilation mode.
- Switch to the "Standby Mode" and return to the previously used ventilation mode.
- Keep this information with the G5 Operator's Manual.
- Distribute the Medical Device Safety Alert immediately to all operators of G5 ventilators.
- Permanently disable the automated suctioning maneuver functionality on all G5 ventilators by using a software key provided by the manufacturer.
- Update the G5 Operator's Manual with the disabled automated suctioning functionality as soon as possible upon its availability.
On April 22, 2014, Hamilton Medical sent letters to customers explaining the issue and advising users that their Hamilton Medical Account Manager would contact them to coordinate the deactivation of the Ventilation Suppression Feature.
1-800-426-6331, Ext 215
Date Recall Initiated:
April 22, 2014
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX