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

Model Number UNITY PACS R11.0.455.12641

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

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

Event Date 07/24/2016

Event Type  malfunction  

Manufacturer Narrative

While merge healthcare investigated the customer's allegation, the assignable cause of the corrupted report could not be determined.The issue will continue to be monitored to determine if additional data becomes available that will further the investigation.

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)(6) 2016, a customer alleged that a report for a stat exam was missing.After further investigation by merge healthcare support, a report tab and a report id was generated within the exam properties.This indicated that a report existed.After reviewing the event logs, it was determined that the report was corrupted.However, the most probable cause for the corruption could not be determined.Merge support was unable to recover the report.Therefore, the report needed to be re-dictated by the customer.When a customer needs to re-dictate a stat exam in order to obtain a report, there is a potential for a delay in diagnosis or treatment.However, there was no reported adverse event or harm to a patient.(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: 5899126
• MDR Text Key: 52854542
• Report Number: 2183926-2016-00705
• 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: 07/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.455.12641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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