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

Model Number UNITY PACS R11.0.403.0

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding missing reports or reports not saving.A review of the complaint history found no increasing trend related to missing reports where the word document was not created.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 10/19/2016, merge was notified that a report was approved, however no report was found.An investigation by merge support determined that a report id was created, however the word document was not created when read.The merge support technician recreated a blank word document in the reports folder, and the report needed to be re-dictated.There was no reported adverse event to a patient.However, reports needing to be re-dictated has the potential to delay patient treatment and/or diagnosis.(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: 6115458
• MDR Text Key: 60436507
• Report Number: 2183926-2016-00787
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.403.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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