Information provided from the customer indicates that when the patient's report did not post to their hospital interface system (his), they did have alternative means of reviewing the report.A review of the customer's cardio software by merge healthcare's technical support staff indicated that a 'hung' application service prevented the patient's clinical report from being delivered to the customer's hospital interface system.Upon restarting the application service, support confirmed that clinical reports began flowing to the customer's hospital interface system normally.
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Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.On (b)(6) 2017, a customer contacted merge healthcare and stated that on (b)(6) 2017 the merge cardio outbound hl7 interface had stopped sending clinical reports electronically to their hospital interface system for approximately 18 hours.During this downtime, a patient was discharged from the facility without a full review of the patient's clinical report.The customer stated that it was necessary for the patient to return to the facility for further testing.The merge cardio software provides users with the ability to review and print clinical reports when they are unable to be delivered to the customer's hospital interface system.Additionally, the system is designed to notify the user if the delivery of clinical reports fails.The notification allows the user to be made aware of report communication issues in order for other methods of communication to be used (print, scan, fax, etc.).With a patient being discharged before staff completed a full review of that patient's clinical report, there is a potential for a delay or incorrect treatment that could result in harm to the patient.However, the customer reported that no harm had occurred.(b)(4).
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