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

Model Number MERGE CARDIO V10.1.0

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Due to the potential for multiple customers to have the same reported problem, a recall has been initiated.

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 alleged to merge healthcare that a software malfunction occurred which allowed a clinical report to be confirmed with an incorrect patient identifier.This malfunction, if not detected, could potentially lead to an incorrect diagnosis and/or treatment of a patient based on the inaccurate information in the report.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations.An internal investigation was completed by merge healthcare (capa: (b)(4) and hhe: (b)(4)).The investigation concluded that there was a possibility of confirming a report with an incorrect patient name/identification.When a report is generated with incorrect patient identification, patient harm is possible due to mistreatment or missed treatment.This affected merge cardio software versions 10.1.0 and 10.1.1 to resolve the issue a recall (2183926-02122016-066-c, z-2709-2016 res 75027) was conducted and all of the affected customers were upgraded to a merge cardio version 10.1.2 or subsequent release.Merge healthcare has completed the upgrades for the affected customers.The fda was notified and the recall was closed on 8/25/2017.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.

• 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: 6081505
• MDR Text Key: 59350749
• Report Number: 2183926-2016-00783
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2709-2016 RES 75027
• Patient Sequence Number: 1