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

Model Number MERGE CARDIO V9.0.8

Device Problem Data Problem (3196)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is working with the customer to investigate the incorrect height transfer in the study info page.A supplemental report will be filed once more information is available.Vrcs-15604 was linked to this case for this part of the issue.

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) 2018 , a customer contacted merge healthcare and stated that the height measurement was importing incorrectly to the merge cardio clinical report causing miscalculation of other measurements.Merge healthcare technical support's initial investigation findings appear to be related to some new echocardiogram imaging carts at the customer's facility.It is possible that the new echo carts may be sending data to merge cardio pacs in an unexpected format therefore resulting in incorrect height measurements.Due to the miscalculation of measurements in the clinical report, there is a potential for incorrect treatment of the patient that could result in harm.However, the customer has not alleged any impact or injury to a patient.(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 05/07/2018.Initial submission found the height was transferring incorrectly to the clinical report due to configuration of the new modalities.Support was able to resolve this issue by applying a fix in vrcs-7635 by updating the readonlydata.Xslt transform file.After this fix was applied, the issue of incorrect height in the clinical report was resolved but height was displaying in the study info page as '1 inch'.Vrcs-15604 was opened and this issue was fixed in v10.3.1.A work around was provided to the customer on how to update the height on the study info screen.The work around was to open a report and then switch to the study info page and it would update the height.The customer upgraded to 11.0.2 on 10/5/2018 which resolved the issue of incorrect height in the study info page.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: evaluation codes: method code: 10 testing of actual/suspected device.Results code: 104 software problem identified.Conclusions code: 21 cause traced to device design.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: 7491195
• MDR Text Key: 108097106
• Report Number: 2183926-2018-00032
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V9.0.8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1