MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

Model Number MERGE PACS V7.1

Device Problems Computer Software Problem (1112); Use of Device Problem (1670)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

After further investigation, merge healthcare development determined this was a code miss.This issue was resolved in pacs 7.2.Merge healthcare also updated the product labeling to include additional guidance regarding the use of voice clips.No further action is required at this time.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2017, during internal testing, a merge employee reported an issue with voice clips saving to the wrong patient.Voice clips are audio annotations and are used differently depending on user's work flow.Voice clips could contain essential information related to treatment/diagnosis.There is a potential that the wrong voice clip may contain data that is required to determine diagnosis and/or treatment decisions.With the wrong voice clip, there is a potential for an incorrect treatment and/or diagnosis to the patient.However, the underlying image is present for the user to read.There was no direct impact to patient care reported.Reference complaint-(b)(4).

Manufacturer Narrative

Supplemental report conclusions: after further investigation by merge healthcare technical support, it was determined that the customer's workflow for the temporary storage and subsequent saving of voiceclips with a patient's report revealed a design deficiency.This issue of a voice clip being saved to the wrong patient's report can occur intermittently when multiple patient voice clips are temporarily stored to the worklist.In order to service the customer's needs, technical support has developed a script to run for the customer to correct the intermittent circumstances when voice clips are associated with the incorrect patient.Merge pacs version (b)(4) includes resolution for the voice clips issue.Merge healthcare performed a health hazard evaluation ((b)(4)) and determined that this situation can result in a less than moderate injury to no injury to a patient.Therefore, based on the results of merge healthcare's investigation, the customer's complaint does not meet the requirements for medical device reporting.The customer's issue did not result in a death or serious injury nor would a recurrence be likely to result in serious or greater harm.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• MDR Report Key: 7016074
• MDR Text Key: 92648745
• Report Number: 2183926-2017-00199
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE PACS V7.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1