Merge technical support shipped replacement hardware, a ups tripp lite 1000va (rma #(b)(4)), to the customer on 24may2017.The faulty unit was returned to merge healthcare by the customer and was received on 08jun2017 for evaluation.The results showed that the ups batteries were enlarged and cracked.The batteries were subsequently replaced and the unit passed all testing.It was confirmed that the replacement hardware corrected the customer's problem.
|
Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2017, a customer reported to merge healthcare that the ups (uninterrupted power supply) was hot to the touch and emitted a sulfur odor.Information obtained from the customer revealed that the problem occurred during a procedure; however, the hemo system was immediately plugged into the hospital electrical supply and the procedure was completed successfully.With a ups becoming hot to the touch and emitting an odor there is a potential for harm.However, the customer confirmed that neither patient nor medical staff were harmed as a result of the failed ups although it was noted that the failed unit had to be immediately removed from the lab due to the strong sulfur odor.(b)(4).
|