Device Problems
Device Stops Intermittently (1599); Radiofrequency Interference (RFI) (2314); Wireless Communication Problem (3283)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Type
malfunction
Event Description
(b)(4).
Manufacturer Narrative
Customer issue could not be duplicated, but for precautionary measures the receivers, motherboard and down converter were replaced.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of any product and this report only represents an enhancement to the reporting criteria going forward.