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

Model Number 12.1.1

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

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

Event Date 07/20/2022

Event Type  malfunction  

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 (b)(6) 2022, an internal merge cardio trainer received feedback from a user who noticed differences between the measurement tool nomenclature and the patient report.The issue is being investigated and work is ongoing between the customer and merge healthcare.A supplemental report will be filed when further information becomes available.This has the potential to delay patient treatment and/or diagnosis or may result in an incorrect diagnosis &/or treatment.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

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

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 07/20/2022.Additional troubleshooting and an investigation was performed by merge healthcare technical support, cardio clinical report engineering, as well as a cross-functional team.It was determined that the nomenclature differences between the measurement labels within the cardio tool and the patient report is not a defect; it is an enhancement request.The labels have persisted in merge cardio since initial release.There have been no other allegations against the tissue doppler labels.The customer's allegation was evaluated and assessed for risk.The nomenclature difference is a no harm issue and has been found to be a non-safety risk to patients or users.Therefore, this issue no longer meets the requirements for adverse event malfunction reporting.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: investigation findings 150 labeling and instruction for.Use/maintenance and 213 no device problem found, investigation conclusions 67 no problem detected and 4316 appropriate term/code not available.The customer's allegation occurred during customer/user training.There was no patient involvement.There are no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.

• 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: laura mccomis ; 900 walnut ridge drive; hartland, WI 53029 ; 2624248731
• MDR Report Key: 15065231
• MDR Text Key: 299306455
• Report Number: 2183926-2022-00010
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100928
• UDI-Public: (01)00842000100928(10)12.1.1(11)211220
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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