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

Model Number MERGE PACS V7.1

Device Problem Computer Software Problem (1112)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is determining the cause of the study being changed from unread to read.A supplemental will be submitted upon findings.

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, a customer reported a study status changed from "unread" to "read" within a few seconds of importing into the pacs system.This caused the study to fall off the doctor's work list and not be read within customer's timeline.The customer confirmed the study was read within approximately one hour and 20 minutes of entering the pacs system.  with a customer being potentially unaware when a new study is added and then removed from the worklist, there is a potential for delay in the diagnosis and/or treatment of a patient that could lead to harm.However, the issue was found by the user and there is no indication of harm to a patient as a result of this issue.

Manufacturer Narrative

After review from support, issue was caused by a timed set status being set for "unread" studies to be updated to "read" status after 5 seconds.Support has removed this timed set status option for "unread" status.No indication of adverse patient impact and no further action taken.

• 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: 7201968
• MDR Text Key: 97988904
• Report Number: 2183926-2018-00006
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1