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

Model Number	MERGE CARDIO V11.0
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation 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 healthcare cardio support disabled this measurement string as requested by the customer for (b)(6) hospitals which resolved the issue in complaint (b)(4) associated with mdr 2183926-2019-00003.The customer called merge cardio support and asked that this measurement also be disabled for their other server that applies to (b)(6) hospitals.Merge healthcare cardio support disabled the requested measurement for server id (b)(4), resolving this complaint (b)(4).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 or Problem 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).
Additional 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.Support disabled this measurement string as requested by the customer for park plaza and tomball hospitals which resolved the issue in complaint-(b)(4) customer called and asked that this measurement also be disabled for their other server that applies to west houston, kingwood, rio grande regional, and valley regional hospitals.Support disabled the requested measurement for server id wst001003, resolving this issue.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
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 8350142
• Report Number: 2183926-2019-00004
• Device Sequence Number: 2253381
• Product Code: LLZ
• UDI-Device Identifier: 00842000100416
• UDI-Public: 00842000100416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: MERGE CARDIO V11.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1