The manufacturer received this device for evaluation in response to a user's report of a thermal event to the nebulizer's ac power cord.There were no initial report of exposed wiring.There was no report of patient harm or injury associated with this reported event.Upon receipt of the device, the manufacturer noted worn insulation damage to the power cord near the reinforced insulation at the nebulizer, with exposure to electrical wires.The exposed wires are melted.The root cause of the event was unable to be determined; however, it is likely the ac power cord had been exposed to forces beyond intended design.Operational checks on the nebulizer passed, no problem found.The innospire essence 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.This device is not labeled for life support.Labeling included with the device warns the user, "it is recommended to have a backup device (e.G.Mdi or battery-operated compressor) for respiratory delivery in case a situation arises when your nebulizer cannot be used (e.G.During a power outage or if your compressor becomes inoperable for any reason)."labeling also warns the user that the power supply cord cannot be replaced by the user.If the power cord becomes damaged, the user is instructed to contact their provider or the manufacturer for replacement as there is no service option." based on the information available, the manufacturer concludes no further action is necessary, and will continue to monitor complaints.There was no patient harm or injury reported.
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