The reported complaint that the thermogard xp ivtm system sn (b)(6) displayed a "factory configure not complete" error message was confirmed during functional testing.The root cause of the issue was an intermittent connection between the input/output printed circuit board (i/o pcb) and the jp1 connector at the rear display head during the system powering up, resulting in lost calibration data.Unrelated to the reported complaint, several issues were observed during the visual inspection of the ivtm system.The wheel casters, ac module power input, drain hose clamp, and set screw on the umbilical cable connector were loose.These observations could be attributed to user handling and transport vibration.The white rollers were worn out, and the pump lid was cracked.Also, the assembly cold well cap and prime switch cover were missing.These observations are related to user mishandling.All the missing parts will be replaced, and the loose connections will be fixed or replaced to address the issues.A review of the event log showed no significant error messages or discrepancies.During functional testing, the thermogard system displayed a "factory configure not complete" error message following the power-on-self-test (post), confirming the reported complaint.Calibration data were lost due to a loose connection between the i/o pcb and the jp1 connector at the rear display head.After inspecting and reconnecting the jp1 connector and re-calibrating the console, it has successfully passed functional and overnight burn-in tests.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the thermogard console with serial number (b)(6).
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The customer reported that during setup for ivtm therapy, t1 input of the thermogard xp ivtm system sn (b)(6) did not register patient temperature.During device testing performed by the customer's biomedical engineer, the thermogard system displayed "factory configure not complete" message.Another thermogard console was used to start the treatment.No patient involvement.
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