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

Model Number MERGE PACS 7.2 PATCH 1

Device Problem Missing Test Results (3267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

Merge pacs is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings.Merge pacs processes and displays medical images from dicom-compliant modalities.The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge pacs software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (vnas), such as iconnect enterprise archive (icea) for image storage, and with radiological and hospital information systems (ris and his) and medical record systems (emr, ehr, etc.).On (b)(6) 2020, a customer contacted merge healthcare to report that some images in a mammography series were not displaying and were missed or skipped.Merge healthcare support is currently in the process of engaging the customer to determine the issue and next steps.When further information becomes available, a supplemental report will be filed.Based on this, there is a potential for delay in treatment that could cause harm to the patient.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 09/30/2020.After investigation by merge healthcare support, it was determined that when a study contains multiple series with same laterality and view, dragging the series with more images into the viewing port and scrolling after passing frame #1 results in the viewing port jumping to the series with fewer images.Two workarounds for this issue are to disable the "automatically stack/scroll mg priors" option or to disable the "automatically split mg series" option.The customer was informed of this and was subsequently able to review the desired series and images.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer.G6 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of additional information.H3 - indication that device evaluated by manufacturer.H6 - evaluation codes: investigation findings 4215 data storage or loss of data.Investigation conclusions 12 cause traced to device design.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 59029
• MDR Report Key: 10609388
• MDR Text Key: 209265081
• Report Number: 2183926-2020-00039
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100409
• UDI-Public: (01)00842000100409(10)7.2.0.157060(11)180115
• Combination Product (y/n): N
• PMA/PMN Number: K192455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 7.2 PATCH 1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1