MAUDE Adverse Event Report: MERGE CARDIO 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 06/08/2022

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 05/12/2022, an internal clinical content reporting engineer found an incorrectly mapped measurement during a training session for merge cardio version 12.1.1.The customer requested left atria and ventricle volume measurements to be configured on merge cardio reports.The customer alleged that the simpson's biplane ef measurement is incorrect and is not updating as expected.Work is ongoing between the customer and merge healthcare clinical reporting engineering.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

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 6/08/2022.After additional troubleshooting by merge healthcare technical support and cardio clinical report engineering as well as a cross-functional investigation into the allegation, it was determined that software coding changes unintentionally caused a defect.The defect was evaluated and assessed for risk.It was assessed with a minor severity and is a low risk.Therefore, this issue no longer meets the requirements for adverse event malfunction reporting.For the issue to be fully resolved, a change to the code is needed.No further action is required at this time.Revised information contained in this supplemental report includes the following: 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 13 device difficult to operate and 104 software problem identified, investigation conclusions 58 cause traced to software coding and 4302 human factors device difficult to operate.This issue occurred on the customer's test environment during customer/user training.There was no patient involvement.There were 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 CARDIO; 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: 14640351
• MDR Text Key: 293723279
• Report Number: 2183926-2022-00007
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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