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

Model Number MERGE CARDIO V10.1

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

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

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

Due to the potential for multiple customers to have the same reported problem, merge healthcare has elected to initiate a recall.

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) 2016, a customer reported to merge healthcare that a fetal patient report was automatically pulling prior measurement data for a prior fetus; however, the attending medical staff immediately noticed the problem before the patients' data was compromised.This was determined to be a potential safety issue in the event that the wrong fetal measurements get referenced, causing over or under diagnosis and/or treatment.(b)(4).

Manufacturer Narrative

An internal investigation was completed by merge healthcare (capa: qs-117993 and hhe qs-117994).These activities determined that the echo.Peds knowledgebase used with merge cardio displays previous report measurements based on the medical record number (mrn).This behavior is expected for pediatric patients.However, a fetal study is based on the mother's mrn.The mother's first fetal exam measurements are used as a reference for subsequent fetal exams for later pregnancies.However, after confirmation, the final report for the subsequent fetus only includes only the second fetus' measurements.In the event that the physician does not notice the first fetus' reference measurements for the secondary/subsequent pregnancy, there is a potential the physician will request a secondary echo study be completed.This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 03/28/2016.To resolve the issue a recall (2183926-03.18.2016-069-c, z-2123-2017 res77124) was conducted and all of the affected customers were upgraded.The recall was closed on 7/17/2017.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: h6 - evaluation codes: methods code: 10 testing of actual/suspected device.Results code: 104 software problem identified.Conclusions code: 12 cause traced to device design.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: 5528416
• MDR Text Key: 41223637
• Report Number: 2183926-2016-00480
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2123-2017 RES77124
• Patient Sequence Number: 1