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

Model Number MERGE PACS V7,1,2

Device Problem Computer Software Problem (1112)

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

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

After further investigation, development personnel determined this was a defect in the code that skips corrupted images.The code was changed in merge pacs version 7.1.2.1.The condition of skipping corrupted images was removed and a load error is displayed to a user while scrolling through a study with corrupted images.The user may be able to re-send the study images from the modality without any corruption which would then allow for scanning through images without issue.

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 identified an issue with image load errors while testing merge pacs version 7.2.1 in their test environment.It was determined that images that failed to load properly were corrupted.The corrupted images were skipped during manual scrolling through a study.There is no warning or error that indicates images have been skipped.There is a potential that a skipped image may contain data that is required to determine diagnosis and/or treatment decisions.Without necessary information, there is a potential for a delay in diagnosis &/or treatment or an inaccurate diagnosis &/or treatment of a patient.At this time, there is no evidence of patient harm or delay due to this issue.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123514
• MDR Report Key: 6796510
• MDR Text Key: 83014521
• Report Number: 2183926-2017-00168
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS V7,1,2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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