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

Model Number	MERGE CARDIO 12.0.1
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Event or Problem 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, an internal investigation revealed that due to two measurements being mapped to the same code, one measurement could overwrite the other in the clinical cardio report.The "mr flow rate" measurement and the "max velocity (mr)" measurement were both mapped to cpcode (10607).Internal resolution is in process.A supplemental report will be filed when more information is available.This has the potential to delay patient treatment and/or diagnosis.There have been no client reports of this issue.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
Additional 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 12/31/2020.After investigation by merge healthcare support, the measurements were remapped and confirmed to be displaying correctly on the clinical cardio report.There were no customer reports of this issue.No further action is required.Revised information contained in this supplemental report includes the following: g6 - indication that this is follow-up report 001.H6 - evaluation codes: 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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• MDR Report Key: 11101546
• Report Number: 2183926-2020-00052
• Device Sequence Number: 3786271
• Product Code: LLZ
• UDI-Device Identifier: 00842000100768
• UDI-Public: (01)00842000100768(10)12.0.2(11)201117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K051649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MERGE CARDIO 12.0.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 02/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1