MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS

Model Number 12.1

Device Problems Computer Software Problem (1112); Use of Device Problem (1670); Application Program Problem (2880)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation into the customer's allegation is ongoing.A supplemental report will be filed when additional information becomes available.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from merge healthcare and other vendors systems including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.Merge cardio is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician generated clinical reports (via structure reporting and template based tools), and to store this information in a database.On 11/01//2022, a pacs application administrator contacted merge healthcare alleging that sometimes a different patient's info appears unexpectedly when utilizing three different systems (epic, merge cardio and tomtec) at the same time.According to the pacs administrator, this can happen when a user is looking up a patient in the emr (epic).The user then returns their focus to the merge cardio application.The user performs a single click, within merge cardio, to highlight/select the patient found in the emr.The user then launches tomtec to view the patient's images.The pacs administrator alleged that sometimes, the highlighted/selected patient changes to another patient on the list, and the information that is shown in tomtec is no longer the patient that was first selected by the user.Merge technical support discussed the issue with the complainant/pacs administrator.According to the complainant, this issue was brought to his attention from two users that experienced the issue.Merge technical support has attempted to contact the users directly but no response has been received at this time.Merge healthcare is investigating this issue.Attempts to replicate the issue have been unsuccessful thus far.Work is ongoing between the customer's site and merge healthcare technical support.A supplemental report will be filed when additional information becomes available.Reviewing and reporting on a different patient's images could result in the implementation of an incorrect or unnecessary treatment plan.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 11/01/2022.After additional troubleshooting and an investigation by merge healthcare, it was determined that multiple factors caused or contributed to the customer's issue.There were multiple applications/tools being used by the customer at the same time.This included merge cardio, a 3rd party application and the customer's emr.The user was reading through and evaluating multiple patient reports, studies and information.While it happened infrequently, the user would select a patient from a list in merge cardio and a different patient's information would appear in the 3rd party application.Merge healthcare worked with the customer to replicate the issue.It was exceedingly difficult to replicate because of the multiple applications/tools.Per good clinical practices, reports or windows should be closed when reading multiple patients.Additionally, records should be confirmed to be the intended patient prior to completing diagnostic or treatment decisions.An enhancement to close 3rd party windows when a different patient is selected is to be included in a future release of merge cardio.There was no indication of patient harm occurring as a result of this issue.No further action is required at this time.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: medical device problem code: 1670 use of device problem, investigation findings 3213 interopreability problem identified, investigation conclusions 19 cause traced to user.

• Brand Name: MERGE CARDIO
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: nadia marchant ; 900 walnut ridge drive; hartland, WI 53029 ; 6045625482
• MDR Report Key: 15881783
• MDR Text Key: 307805083
• Report Number: 2183926-2022-00012
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100928
• UDI-Public: (01)00842000100928(10)12.1(11)210122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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