Additional information: d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Received device in with no damaged.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord, and turned on the power switch.The reported issue was not confirmed.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.
|