The manufacturer received an innospire elegance device for evaluation of "low air flow".There was no patient harm or injury reported.Upon receipt of the device, the manufacturer noted physical damage to the ac power source, which resulted in exposed conducting wires, and a risk of shock to the user.There was no evidence of thermal damage.Although the root cause of the observed damage was not confirmed, this type of damage is typically a result of the ac power cord being subjected to forces beyond intended design.The innospire elegance device 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 children and adults.Labeling warns the user "it is recommended to have a backup device for respiratory delivery in case a situation arises when your nebulizer can not be used".The user is also cautioned that the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option).This device meets all relevant ul and iec standards.This device is not labeled for life support.The manufacturer will continue to monitor the complaint records for similar reported failures.Based on the available information, the manufacturer concludes no further action is necessary.
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