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

Model Number MERGE CARDIO V10.2 P1 AND P2

Device Problem Data Problem (3196)

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

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

At this time this issue is still being investigated by merge healthcare, when more information becomes available a supplemental will be filed.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information 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.On (b)(6) 2019, a customer alleged that clinical reporting was logging off without saving previously entered report data.This could lead to a delay in patient care while redoing the clinical report.Delay in treatment has a potential to lead to harm.However, there is no allegation of harm to a patient 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 (b)(6) 2019.Investigation found that cardio has two timeouts used for reporting.One is for the reporting session and one for the browser on the client hosting the session.These timeouts should always match and by default are set to 60 min.What happened at nicklaus is unique in that they don't do the typical reporting workflow that most sites use.At most sites, users use the mouse as well as macros to enter findings into the report.Since reporting is hosted on the cas, each finding is saved to the database immediately with each click.At nicklaus however, they prefer to enter their findings by free text summary entries which allows them to type in full sentences and paragraphs.The difference is the data they enter this way is not saved until the user clicks ok.If they have this free text summary box open for longer than the reporting session timeout, they may not know they have timed out until they click ok which leads to them thinking their data was lost.In reality it was never submitted.Support changed the sessiontimeout and reportstatetimeout to 2 hours, which should give doctors plenty of time to enter data into report.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.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: 10 - testing of actual/suspected device.Results code: 213 - no device problem found.Conclusions code: 4310 - cause cannot be traced to device.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 53029
• MDR Report Key: 8573177
• MDR Text Key: 145617137
• Report Number: 2183926-2019-00020
• Device Sequence Number: 1
• Product Code: LLZ
• 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
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.2 P1 AND P2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1