The manufacturer became aware of an event alleging that a performamax full face mask's elbow disconnected from the mask hub while in use with a v60 ventilator on a covid-19 patient.The was no allegation of malfunction against the ventilator.The user desaturated, became hypoxic and bradycardic, and medical intervention was required.The mask will not be returned for evaluation due to covid 19 contamination.Evaluation of same mask and lot number will be performed for investigation if available.A follow up final will be submitted when the investigation is completed.
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The manufacturer became aware of an event alleging that a performamax full face mask's elbow disconnected from the mask hub while in use with a v60 ventilator on a covid-19 patient.There was no allegation of malfunction against the ventilator.The user desaturated, became hypoxic and bradycardic, and medical intervention was required.The mask will not be returned for evaluation due to covid-19 contamination.The product investigation laboratory purchased two performax mask assemblies, one small (lot # 88457011) and one long (lot # 93126293) performax mpu dom with ee leak 2 and se.The masks were received in january of 2023.Both masks were tested for elbow pull-out torque per prd # (b)(4), which requires the pull-out torque to be greater than 10 lbs.The large mask registered 65.34 lbs of pressure.A retest measured 57.33 lbs of pressure.The small mask registered 66.67 lbs of pressure.The retest measured 47.62 lbs of pressure.This mask has a history of complaints of the elbow coming out too easily, per customer.Due to the elbow being a force fit, the pull-out torque depends on how the elbow was placed in the swivel.Both masks were set up using a v-60 ventilator and the settings provided by the customer.Neither mask leaked nor was disconnected from the mannequin during the one hour each was tested for.Could not duplicate the customers' complaint. .
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