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

Model Number	MERGE CARDIO 11.1.1
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
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, a customer contacted merge healthcare support stating that a recent report was unavailable in their emr and that this had resulted in a delay of care for a patient.Merge healthcare support found that the report failed to export to the emr because hospital staff entered "/wife" in the phone number field of the report and the hl7 outbound message will fail if it encounters an unexpected format, such as letters and/or special characters in a field designed for only numbers.Merge healthcare support was able to remove these characters from the field in question and confirmed that the export of the report to the emr was successful.Additionally, merge healthcare support worked with the client to change the hl7 fields so that phone numbers are no longer included, so as to prevent this issue from causing further possible delays to patient care.No further action is necessary at this time.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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• MDR Report Key: 10856392
• Report Number: 2183926-2020-00048
• Device Sequence Number: 10908699
• Product Code: LLZ
• UDI-Device Identifier: 00842000100751
• UDI-Public: (01)00842000100751(10)11.1.1(11)190724
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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 11.1.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• 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