The manufacturer received the device for investigation.There was evidence the device blower had malfunctioned, resulting in the delivered pressure being below specification.There was evidence of dirt/hair contamination internally to the device.There were no electrical issues noted.The innospire mini is intended to provide a source of compressed air for medical purposes.It is to be used with a pneumatic (jet) nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.Labeling included with this device warns the user "it is recommended to have a backup device (e.G.Mdi) for respiratory delivery in case a situation arises when your nebulizer cannot be used (e.G.During a power outage or if your compressor and/or battery becomes inoperable for any reason.).This device is not labeled for life support.Although the user reported being hospitalized for 2 days, there has been no further information provided as to the reason for the admission.There was no serious or permanent injury reported.Based on the information available, the manufacturer concludes no further action is required.
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