MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number UNITY PACS R11.1.1

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The report was accidentally approved with missing information and was sent without conclusion.When approving reports, merge unity pacs is interacting with third-party software (in this case, microsoft word), and that the control over the document itself is limited.Merge unity pacs has precautions in place when the radiologist follows a normal recommended workflow.The workflow expectation is for the caution statement in the report template to be replaced with no room in between (when using speech recognition, the whole caution statement is automatically highlighted, and the intention is for the radiologist to overwrite it with the actual conclusion text).A pop-up warning occurs if the caution statement in the report is still present.There is still room for user error if the caution statement is removed but not replaced by a conclusion, it is possible to approve the report with text missing.A review of the complaint history indicates there is no significant trend.Trending will continue to be monitored.

Event Description

Merge unity pacs a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On (b)(4) 2017, merge healthcare was notified from the customer that an incomplete report was sent out to the referring physician without the mention of a lung nodule on (b)(6) 2017.A radiologist from the customer site read a patient's case on (b)(6) 2017 and found an abnormality in the lung.The radiologist called the referring doctor to inform them of the abnormality and recommended that the patient have a follow up ct.However, the report that was sent out to referring doctor had no mention of the lung nodule in the report body.Additionally, there was no information regarding the nodule in the conclusion section of the report.The referring doctor's office called back for clarification because they were confused by the report which had no mention of the lung nodule.The radiologist at the site then spoke to the referring doctor and issued an addendum report with complete information.There were no known adverse events to the patient.However, sending an incomplete report to a referring physician with missing information could potentially lead to a delay in treatment and/or diagnosis that may lead to harm.(b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6433738
• MDR Text Key: 70866006
• Report Number: 2183926-2017-00078
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1