OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst
AUDIENCE: Risk Manager, Patient, Nursing
ISSUE: The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst. See FDA Recall notice for a list of affected Lot and Model numbers.
BACKGROUND: The firm has received a total of 2 reports of incidents in which the device has malfunctioned, including 1 injury and 1 death. When the injury occurred, the unit was dropped from 4 feet; where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.
Portable oxygen units provide oxygen to patients to help regulate their breathing while allowing them to travel around. Pressurized oxygen is stored in a special container and is delivered to the patient through tubing that is placed in the nostrils or through a mask.
RECOMMENDATION: Users and User Facilities (Hospitals, Health Care Facilities, Health Care Service providers, etc.):
- Locate and identify any OxyTOTE/oxyQuik/AirTOTE product in your possession.
- Review the instructions to determine if the product IS or IS NOT marked and if remediation is needed.
- Contact your OxyTOTE/oxyQuik/AirTOTE supplier or Medical Gas Provider directly to schedule the remediation of product in your possession.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the FDA Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458868.htm