Urgent medical device correction for incontinence management system
There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
Baxter International Inc. has issued an urgent medical device correction for the WatchCare Incontinence Management System due to potential for radio frequency interference with other medical devices, the FDA announced on Oct. 24.
The system, which is designed to discreetly alert the caregiver in the case of an incontinence event, radiates radio frequency that might affect other devices in the vicinity, including those on both patients and staff members. Such devices include insulin pumps, blood glucose sensors, fetal Dopplers, telemetry devices, bladder scanners, and infusion injection pumps. Interference in all but two cases occurred at distances less than 1 m. No serious injuries or deaths have been reported.