Health Canada has recalled Omnilab Advanced sleep apnea machines because of performance issues. People should contact the manufacturer if they require any additional information, according to a Wednesday health product recall. All lots are being recalled. The model number for the affected sleep apnea machines is 1044278. Health Canada said the affected products feature a ventilator operative alarm, which occurs when the ventilator detects an internal error or condition affecting therapy. It pointed out this might manifest with the ventilators rebooting intermittently for five to 10 seconds, restarting therapy, and returning to delivering therapy with same patient settings. While they might return to same patient settings, they can revert to factory default settings. When there are three reboots within a 24-hour period, they will enter a ventilator inoperative state. They might enter a ventilator inoperative state without a reboot preceding this condition. Health Canada concluded by saying any of the above scenarios could result in interruption or loss of therapy, which might lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure and insufficiency, or potential death in the most vulnerable patients.
Health Canada has recalled Omnilab Advanced sleep apnea machines because of performance issues. People should contact the manufacturer if they require any additional information, according to a Wednesday health product recall. All lots are being recalled. The model number for the affected sleep apnea machines is 1044278. Health Canada said the affected products feature a ventilator operative alarm, which occurs when the ventilator detects an internal error or condition affecting therapy. It pointed out this might manifest with the ventilators rebooting intermittently for five to 10 seconds, restarting therapy, and returning to delivering therapy with same patient settings. While they might return to same patient settings, they can revert to factory default settings. When there are three reboots within a 24-hour period, they will enter a ventilator inoperative state. They might enter a ventilator inoperative state without a reboot preceding this condition. Health Canada concluded by saying any of the above scenarios could result in interruption or loss of therapy, which might lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure and insufficiency, or potential death in the most vulnerable patients.
