The customer reported that the pulse (spo2) vitals trend is missing.The surgeon lost track of the patient's pulse rate before and after an operation.It was reported the patient's life will be affected.After checking through the vitals trend, it was identified the pulse under spo2 was missing.A configuration setting was done to add the pulse (spo2) into the vitals trend.After completion of the configuration, the pulse is now being shown in the vitals trend.
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Problem statement: it was reported that patient spo2 vital trend was missing during a procedure.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Patient/user involvement : was the device being used on a patient at the time of the event, including for the purposes of diagnosis? the device was in clinical use on a patient at the time of the event.Was there any adverse event to the patient or user? if yes, describe? no adverse event occurred.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no adverse event occurred.Complaint evaluation a philips field service engineer (fse) went to the customer site.The engineer was able to confirm the product was functioning as intended.The device configuration did not permit the spo2 vital trend to display.Customer resolution and conclusion the customers issues was resolved by performing a configuration change.After the configuration change the spo2 vital trend displayed on the device.No further investigation or action is warranted at this time.
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