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

Model Number UNITY PACS R10.0.436.77

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

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

Event Date 07/14/2016

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.The assignable cause of the loss of report was most likely related to the report file not uploading to the server.

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 07/14/2016, merge was notified that the station crashed while dictating a report, subsequently, the report was missing.The customer reported that the system stated there was an existing report when the user tried to re-dictate the report, however no existing report could be found.After further investigation by merge support, it was determined that the most probable cause of missing report was due to the report file not uploading to the server.The merge support technician was not able to recover the report or find the word document file for the report.Therefore, the report was lost and 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: 5875857
• MDR Text Key: 52621684
• Report Number: 2183926-2016-00683
• 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: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNITY PACS R10.0.436.77
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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