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

Model Number MERGE CARDIO 11.0.3

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

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

Event Date 09/08/2020

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 that the mitral regurg pisa radius was mapped incorrectly.Upon investigation and troubleshooting by merge healthcare support, the measurement was removed and remapped.It was confirmed to them be mapped correctly in the customer's system.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).

• 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 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: brian bell ; 75 binney street; cambridge, MA 02142-1123 ; 3123540189
• MDR Report Key: 10504706
• MDR Text Key: 206123515
• Report Number: 2183926-2020-00033
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100416
• UDI-Public: 00842000100416
• 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
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO 11.0.3
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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