RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Tightness/Pressure (2463); Abdominal Distention (2601)
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Event Date 08/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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The determination could not be made that the device failed to meet specifications.The device was being used for treatment when the reported event occurred, and there is a relationship of the device to the adverse event.Gastric distention is a known patient issue with positive pressure ventilation.
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Event Description
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A physician reported that a patient had gastric distention.The patient was admitted for acute exacerbation of chronic obstructive pulmonary disease, heart disease, type 2 respiratory failure, respiratory acidosis, metabolic alkalosis and hypertension.The patient was on the ventilator for approximately one week, and on (b)(6) 2017, the patient had flatulence, could not lie supine and had chest tightness.The ventilator was removed and the patient was treated with tongli shenling graunules 10g for spleen and stomach three times a day) and domperiodone maleate tabs 12.7mg.After one week of treatment the patient has no further symptoms and the naso-gastric tube was not required any longer.
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Manufacturer Narrative
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The authorized service provider, (b)(4), confirmed there were no failures with the ventilator.It was confirmed that gastric dilation was a described side effect in the user manual.The clinical staff at the hospital were given further training on this.
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Search Alerts/Recalls
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