Customer reports: the product is not holding air.Per additional information received from the customer on (b)(6) 2023, the device was used on a resident and it came out on it¿s own, so it was tested to see if it was holding air.When air was put into the balloon and it was checked, the air was gone, the balloon was deflated.It is unknown how long the device was out but not more than one hour.The resident was sent to the er every time the device has to be replaced at an unscheduled time.The patient is stable.
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Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.H3: device evaluation comment - the device will not be returned for evaluation because it has been discarded.
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