Hamilton G5 Ventilator under Class 1 FDA Recall

The Food and Drug Administration (FDA) has issued a safety announcement about the recalled Hamilton G5 ventilator.

The ventilator, now under Class 1 recall, may stop working without sounding an alarm when the operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver), the FDA warns.

This ventilator problem can occur under the following conditions:

• When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected.
• 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 operator does not intervene, the patient may not receive enough oxygen and could suffer serious injury or death. The recall notice on the FDA web site has a list of affected catalog numbers. Because of possibility of death, this is a Class 1 device recall, the FDA’s most serious recall category.

The recalled ventilator is the G5 Ventilator V2.00 and V2.31, which was distributed from March 2007 to March 2014. Hamilton says it has received one report of a ventilator malfunction and no reports of injuries or deaths.

The FDA advises that after a suctioning maneuver has been done, the operator must verify that the ventilator is operating properly. If ventilation has stopped, the operator must re-establish ventilation. The operator can do the following:

• Press the “Manual Breath” key on the ventilator’s front side.
• Change the ventilation mode.
• Switch to the “Standby Mode” and return to the previously used ventilation mode.

The FDA advises operators to keep this safety information with the G5 Operator’s Manual. The agency advises distributors to send the Medical Device Safety Alert immediately to all operators of G5 ventilators. The distributor should permanently disable the automated suctioning maneuver function on all G5 ventilators by using a software key provided by the manufacturer. In addition, the distributor should update the G5 Operator’s Manual with the disabled automated suctioning functionality as soon as possible

The FDA encourages health care professionals and patients to report adverse events or side effects through the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report. Reports can be made online, by mail, by phone, or by fax.

from Parker Waichman http://www.yourlawyer.com/blog/hamilton-g5-ventilator-under-class-1-fda-recall/