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It was reported by the baxter respiratory trainer that the patient¿s spo2 dropped to the 60¿s and the patient¿s mouth turned blue during training on the synclara device.There was no allegation of a device malfunction, and medical intervention was not required.The patient in this event is a 35-year-old male with a medical history of traumatic brain injury s/p mva in 2016, hydrocephalus, intra-cranial hemorrhage, seizure disorder, cardiac arrest, deep vein thrombosis, peg dependence, tracheostomy s/p decannulation, and healing stoma covered with adhesive dressing.Per clinical notes, the patient has had intermittent oxygen requirements, as he is on continuous pulse oximetry while living at home with his wife.He has a concentrator and requires 1 to 2 lpm intermittently.Wife notes that he has coughing spells and when he expectorates significant sputum, his oxygen improves drastically.Per the patient¿s wife who is a rn, the patient¿s lungs are diminished in the bases.On (b)(6) 2023, the patient and his wife received training and therapy was initiated on the synclara device via adult face mask.The trainer initially attempted 5-7 cycles of therapy on the medium preset setting and although the patient tolerated this well, therapy did not seem effective.Next, the trainer attempted 7-9 cycles of therapy on the high preset setting but air leak from the patient¿s tracheal stoma was much more pronounced.Therapy was repeated on the high setting with light pressure applied to the stoma covering to minimize air leak and therapy seemed to be more effective with improvement in chest rise observed.During the 12th cycle of a 20-cycle therapy on the high setting, the trainer noticed the patient¿s spo2 was dropping on the continuous pulse oximeter but there appeared to be artifact according to the waveform.The patient¿s wife further stated the pulse oximeter did not have a proper pleth wave, thus the spo2 reading was interpreted to be inaccurate by the trainer and wife.The patient completed 20 cycles with no break and after removing the mask from the patients face, it was noted by the trainer that patient¿s mouth was blue.The wife stated the patient had become annoyed with repeated therapy attempts and seemed to be holding his breath towards the end of the 2-minute treatment and his skin was a ¿a little blue¿ at the end of therapy.The patient¿s skin color returned immediately and spo2 recovered to baseline (95% on room air, hr 85-91 bpm) in less than 1 minute after therapy was discontinued.The baxter respiratory clinician advised the trainer to discontinue therapy and notify the patient¿s provider of the reported event.If the patient¿s provider would like to attempt therapy again, the trainer was advised to trial the patient on other settings with a break between cycles.In the meantime, the wife would continue with vest therapy and duoneb treatments.The patient¿s wife later requested to return the synclara device.The synclara cough system is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.The system supplies positive insufflatory pressure (inhale) to the airway with the intended goal of inflating the lungs.The system then rapidly shifts to supply negative exsufflatory pressure (exhale) with the intended goal of rapidly deflating the lungs to simulate a high expiratory flow which stimulates an effective cough.Oxygen desaturation is a below-normal level of oxygen in the blood.Normal pulse oximeter readings range from 94 to 100 percent a value under 90 percent is considered low.Oxygen desaturation can be contributed to disorders such as copd, emphysema, respiratory failure, or other pulmonary disorders.Treatment typically consists of oxygen measurement (via blood test or pulse oximetry) and oxygen administration.In this event, although the patient¿s oxygen level was clinically below normal range, and the change was temporary, the event of oxygen desaturation to the 60¿s accompanied by cyanosis is considered life-threatening, concluding a serious injury occurred.The patient recovered to baseline at home under supervision of a trained healthcare professional after discontinuing therapy and did not require medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The ultimate cause of the reported drop in oxygen saturation is unknown, but likely multifactorial due to the patient's medical history, patient possibly holding his breath at the end of therapy, and therapy intolerance.Additionally, the drop in oxygen saturation was initially misinterpreted on the pulse oximeter due to perceived artifact.There was no allegation of a device malfunction.Based on this information, no further action is required.
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