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

Model Number MERGE CARDIO V10.1.1.1

Device Problem Data Problem (3196)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Measurement corrections were requested for removing unwanted measurements, mapping missing measurements and to correct inconsistencies with derived measurements.Merge healthcare is working with the customer to resolve this issue.When more information becomes available, a supplemental report 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 12/19/2016, a customer contacted merge healthcare and stated that diagnostic measurements taken by their modality needed to be corrected.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.However, the customer has made no indication of patient safety issues while working with cardio support.(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 01/18/2017.At the time of original submission, the customer stated that they wanted measurements removed from the clinical report, additional measurements mapped and that there was a discrepancy in some of the derived measurements.The discrepancy seems to be caused by the difference in the way that bsa is calculated on the sending modality and merge clinical reporting.The bsa in merge and the customers emr is the same but is different on the sending cart.The customer wanted more information from the sending vendor on how they calculate bsa prior to proceeding with any changes and the case was closed.A search of customer cases did not reveal any new cases regarding this issue with a discrepancy of measurements or any other measurement cases.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.The measurements can be manually changed by the physicians as they have been doing.Revised information contained in this supplemental report includes the following: g1-2 - updated contact office - name/address/email; 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: 67 - no problem detected; 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: 6262799
• MDR Text Key: 65218721
• Report Number: 2183926-2017-00019
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1.1.1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: 07/21/2017
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1