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

Model Number MERGE CARDIO V11.1.1

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

A customer contacted merge healthcare and stated that they had incorrect and missing measurements on the clinical report.Support has been working with the customer to get the information needed to be able to investigate this issue.When more information becomes available a supplemental with be submitted.

Event Description

Indications for use: 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.Merge cardio is software comprised of modules that perform under standard "off the shelf" personal computers and servers running the (b)(4).Merge cardio is image data storage and display software that accepts dicom (digital imaging and communications in medicine) image data files from multiple modalities.It accepts text data using other standards-based formats including but not limited to hl7 and xml.Merge cardio is an internet/intranet network system that is designed for small and large, multi-user environments.The merge cardio network structure (including server and workstations) provides for the system's database management, storage, printing, and all dicom/hl-7 interface services.On (b)(6) 2020, a customer contacted merge healthcare and stated they were missing measurements and some measurements were incorrect.Due to an incorrect values displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.Reference case (b)(4), 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 03/31/2020.At the time of original submission, the customer had not responded with information that support requested in order to investigate the issue of incorrect measurement mapping.The customer stated they did not have time to pursue the issue and to provide support with the requested information to allow them to investigate and resolve the issue.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.The measurements can be manually changed by the physicians as they have been doing.Revised information contained in this supplemental report includes the following: g4 - date new information received by manufacturer.G7 - 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: method code: 4119 - insufficient information available.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.H10 - indication of additional manufacturer information is contained in this follow-up report.

• 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
• MDR Report Key: 9925049
• MDR Text Key: 200830896
• Report Number: 2183926-2020-00012
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: 00842000100041
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V11.1.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1