It was reported that after the patient was sedated, the patient underwent a heart exam.In the middle of the exam, the transducer generated a usacquisitionhw_0 error and subsequently locked up the ultrasound system.The user rebooted the ultrasound system and the functionality was restored.The transducer was removed and a new transducer was reinserted into the patient to continue and complete the exam.There was a delay of 10-15 minutes to replace the transducer.There was no loss of data and there was no patient adverse event reported.No additional information was provided.
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This supplemental report is being submitted to update the device available for evaluation; provide the date new information was received and the type of report; provide the type of reportable event, provide the type of follow-up, update the device evaluated my manufacturer, provide the device manufacturing date, and update the event problem and evaluation codes; and provide the device evaluation results.The z6ms transducer referenced in this report was returned to siemens for investigation.During visual inspection, no visible damage was found on the articulation sleeve area.System testing was executed and no system error was able to be reproduced.Additional functional tests were conducted and the transducer was confirmed to be performing to its specifications.Based on the results of the investigation, there was no trouble found as the root cause of the reported error could not be identified.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.(b)(4).
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