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

Model Number MERGE CARDIO V11.0

Device Problem Data Problem (3196)

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

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The customer called and requested to stop populating the tricuspid peak gradient during diastole (trv peak grad, d (mm hg)) measurement as it appeared to be populating the merge cardio clinical report incorrectly.Upon investigation it was found that the modality (imaging device) was sending tr maxpg text string to both trv peak grad, during distole and trv peak grad, during systole.For this site, the report text string doesn't specify, and it appears to be populating the opposite.Hence the discrepancy on the merge cardio clinical report.Merge cardio technical support disabled this measurement text string, as requested by the customer, for park plaza and tomball hospitals which resolved the issue.At this time the customer has not be able to be reached to confirm that no patients were harmed due to this issue.When more information becomes available, a supplemental will be submitted.

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 contacted merge healthcare and stated that diagnostic measurement taken by their modality was incorrect and needed to be disabled.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 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.Information obtained from the customer stated that the tricuspid peak gradient during diastole (trv peak grad, d (mm hg)) measurement was populating the report with a value that was well out of normal limits and was readily apparent since go-live and in most cases was removed from the report by cardiologists.This issue was not known to cause harm to the patient and has been resolved by merge support by disabling the measurement at park plaza and tomball hospitals.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: 3208 - configuration issue.Conclusions code: 21 - caused traced to infrastructure.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: 8348342
• MDR Text Key: 136854393
• Report Number: 2183926-2019-00003
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100416
• UDI-Public: 00842000100416
• 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: 01/23/2019

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 V11.0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1