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

Model Number MERGE CARDIO 10.1.2

Device Problems Application Program Problem: Parameter Calculation Error (1449); Patient Data Problem (3197)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2020

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) 2020, a customer contacted merge healthcare and stated there were issues with measurement mappings in the cardio clinical report.They stated that the ivc (inferior vena cava) measurement was populating the ivs (interventricular septum) field, that the aortic regurgitation deceleration measurement had too many digits, and that the descending aorta id appeared to be mismapped.At this time, investigation between the customer and merge healthcare is ongoing.Due to incorrect values displaying in the cardio clinical report, there is a potential for incorrect treatment of a patient that could result in harm.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 7/22/2020.After additional troubleshooting by merge healthcare technical support, the measurements in question were re-mapped and tested and confirmed to be displaying correctly.The customer was repeatedly nonresponsive and needed many follow ups to confirm.No further action is required.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.H6 - evaluation codes: health effect - clinical code: 4582 no clinical symptom/sign.Health effect - impact code: 2199 no health consequences or impact.Medical device problem code: 1449 application program problem: parameter calculation error.Component code: 4755 part/component/sub-assembly term not applicable type of investigation: 10 testing of actual/suspected device.Investigation findings: 3200 incorrect data definition.Investigation conclusions: 143 quality control deficiency.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
• MDR Report Key: 10311685
• MDR Text Key: 200827009
• Report Number: 2183926-2020-00027
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO 10.1.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1