R82 A/S, FSN-PMS 2021 14 FSCA, Push brace | Production problem with the chrome surface in the period mentioned above. The problem results in the chrome surface peeling off and in some cases creating a sharp edge. The potentially sharp edge can occur on the push brace where the caregiver is likely to place the hands, so the risk for a cut is high. | | imtmedical ag, FSN-FSCA-2021-001, imtmedical bellavista ventilator | Imtmedical ag has received reports that on bellavistaTM ventilators with generation 6 (G6) hardware (see affected devices above), ventilation is ceased during clinical use, and ventilation monitoring waveforms and parameters frozen (not updated). The ventilator generates a continuous audible and visual high priority alarm for technical failure 305. Ventilation is suspended until the unit is... | | |