The issue has been resolved and the device remains on site and in use.A health hazard evaluation (hhe) was performed and concludes the following: compurecord interfacing engine has a decoding defect that causes data received from approved devices to be missing or incorrect.This data is missing or incorrect to the user.The potential hazardous situations identified due to this defect include a hazard for delayed patient treatment due to missing data or incorrect data out of bounds and a hazard for incorrect patient treatment due to incorrect data.Based on conclusion of hhe the risks are acceptable and it has been determined that this event is no longer reportable.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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