Problem statement it was reported to philips that the device failed to obtain a 12 lead ecg reading when the lead set was re-installed after being unplugged to move a patient.Complaint evaluation the customer requested that an authorized field service engineer (fse) be dispatched to the customer site.An evaluation was performed and the fse was unable to replicate the reported failure.The fse verified that there were no noted issues with the cables, connections or leads associated with the ecg function that could have caused or contributed to the original allegation.The fse reported that they were able to acquire a 12 lead reading and that the unit was fully functional.Customer resolution and conclusion philips is unable to rule out that a malfunction did not occur.As the issue could not be replicated during evaluation, a definitive cause for the alleged failure could not be determined.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? (yes, no, unknown) yes was there any adverse event to the patient or user? if yes, describe? (yes, no, unknown) no if there was an adverse event, did the device cause or contribute to the adverse event, and how? (answer yes, no, or unknown.If no or unknown, provide explanation including any gfe attempts.) no, there was no reported adverse event to a patient or user as a result of the issue.
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