FDA issues highest alert for over 9,000 high-tech hospital beds that could KILL patients: Smart mattresses first deployed in 2018 are recalled because they cause vital medical equipment to malfunction
Thousands of high-tech hospital beds have been recalled amid fears they could kill or lead to life-threatening injuries to patients.
Smart beds have been found to interfere with nearby medical devices, including baby heart rate monitors, infusion pumps and other essential equipment.
Illinois-based healthcare company Baxter International is recalling 8,550 units of its WatchCare incontinence management system.
They are mainly used in intensive care rooms and operating theaters and alert caregivers when incontinent patients have had an accident. The faulty units were first deployed in August 2018.
Staff at hospitals where the beds are used are asked to recheck any unexpected or atypical results and closely monitor infusions.
The US Food and Drug Association (FDA) has classified the recall as “Class 1” – the most serious type.
One of the affected smart beds is the Centrella P7900B bed with WatchCare
The WatchCare System for Progressa Bed may also interfere with medical equipment
Recalled Product Models
- P7900B Centrella Bed with WatchCare
- P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. AJ
- P00697902: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. K
- P00697903: Hospital Bed Accessory, WatchCare System for Progressa Bed
- P00697905: Accessory for hospital bed WatchCare system for Centrella bed
Affected devices may include (but are not limited to):
- telemetry devices
- bladder scans
- fetal monitors/dopplers
- infusion pumps
- insulin pumps
- blood glucose sensors
The recall was based on 96 reported interference complaints with no reports of product-related injuries or deaths, the FDA said.
All but two of the 96 interference incidents occurred when the medical device was within one meter of the hospital bed.
The beds are thought to be used on a wide range of patients, from women in labor to people with dementia.
Baxter – one of the nation’s leading hospital bed suppliers – notified customers of the recall in a letter in late September.
In the letter, Baxter warned users of WatchCare’s potential for radio frequency interference with other medical devices.
The correction letter was updated last month to include actions healthcare professionals could take in the event of a malfunction or interference.
The device has also been found to interfere with insulin pumps, blood sugar sensors and bladder scans.
Baxter said it researched the location and removal of the device from clinical care areas, where possible.
All hospitals with beds should identify all affected devices and discontinue use of the WatchCare system accessory while it determines the cause of the issue, Baxter said.
In the meantime, the company will also be in contact with users to arrange the temporary deactivation of the accessory.
Physicians and patients who experience adverse product-related reactions should report them to the FDA’s Safety Information and Adverse Event Reporting Program via an online form, mail, or fax.
Healthcare professionals should use “standard non-RF incontinence management pads” until the problem is resolved.
Many of the recalled WatchCare devices were manufactured by Hillrom, which was acquired by Baxter in late 2021.