Model Number MERGE PACS 6.6.3.1 |
Device Problems
Image Display Error/Artifact (1304); Loss of Data (2903)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, merge healthcare is continuing their investigation and will determine if any further actions are required.It should be noted that there is other clinical information that can be utilized by customers to provide additional context regarding the treatment of a patient.
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Event Description
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Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and threedimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016, a customer reported they used the qc editor tool to split a study and found the changes were not saved after saving and reopening the study.The qc editor tool did not give the customer a warning that changes were not saved.The qc editor tool is used to split, merge and/or delete series of images in a study.There is a potential for a delay in treatment that may lead to harm however the customer has not indicated that any harm to a patient occurred as a result of this issue.(b)(4).
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Manufacturer Narrative
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Merge healthcare pacs support completed a query that extracted all the records from the event log that indicate failures of the qc operation and corrected these studies.Development resolved this issue in version 6.6.3.2 and upgraded this clients servers to version 6.6.3.2.No further actions are required at this time.
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Search Alerts/Recalls
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