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

Model Number 10.1.2

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 01/06/2022

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 12/13//2021, a customer contacted merge healthcare to report that the la volume index measurement was mapped incorrectly.Work is ongoing between the customer and merge healthcare technical support and a supplemental report will be filed when further information becomes available.This has the potential to delay patient treatment and/or diagnosis.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 1/6/2022.After additional troubleshooting by merge healthcare technical support, the height measurement was found to be cause of intermittent left atrial volume index value discrepancies.A combination of the complainant's imaging modality settings and merge cardio software settings would, on occasion, lead to an issue with height units.Settings on the imaging modality and merge cardio were adjusted to ensure that the height would store correctly.The setting adjustments were tested and confirmed that the left atrial index value issue was resolved.No further action is required.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 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
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 waknut ridge drive; hartland WI 53029
• Manufacturer Contact: brian bell ; 75 binney street; cambridge, MA 02142-1123 ; 3123540189
• MDR Report Key: 13180322
• MDR Text Key: 290967853
• Report Number: 2183926-2022-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10.1.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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