MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE CARE PACS; SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC

Model Number MERGE EYE CARE PACS 5.3.1

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate the customer's reported issue.When additional information becomes available a supplemental report will be submitted.

Event Description

Merge eye care pacs is intended to be used for viewing, communicating and storing digital images derived from an image modality.Pacs functionality includes, recording, annotating, calculations, patient medication/interaction information, monitoring & tools to modify/enhance image& demographic data.On (b)(6) 2019, merge healthcare received information from an account regarding incorrect information pulling into patient's record.According to the information received, an eye care professional could be looking at patient data and the information will switch to the previous patient's information.This issue is being reported due to the potential for harm related to the possibility of incorrect diagnosis or treatment being administered to the wrong patient.No patient harm occurred as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 02/22/2019.Additional investigation occurred into the root cause.It was determined the issue occurs due to a software change that was made.This issue only occurs when a customer follows a specific workflow, within a specific version of eye care pacs.The customer was provided a recommendation on another workflow and the issue is to be corrected in a future release.

• Brand Name: MERGE EYE CARE PACS
• Type of Device: SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, WI 53029
• MDR Report Key: 8361003
• MDR Text Key: 136854861
• Report Number: 2183926-2019-00006
• Device Sequence Number: 1
• Product Code: NFJ
• Combination Product (y/n): N
• PMA/PMN Number: K110006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE EYE CARE PACS 5.3.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1