MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problems Application Program Problem (2880); Blocked Connection (2888)

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

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting efforts between merge healthcare and the customer are still underway.For this reason, (b)(4) (conclusion not yet available-evaluation in progress) was used.When more information becomes available, a supplemental report will be submitted.

Event Description

Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the hemo client pc experienced a "critical error" during a procedure after sedation and active monitoring were initiated.This required the user to reboot both the hemo monitor and client pcs that resulted in a loss of patient monitoring during the reported delay, ~10-15 minutes.With merge hemo not capturing physiological data, there is a potential for delay of treatment that could cause harm to the patient.The customer reported that the procedure was completed successfully using a third party ekg monitor and manually charting of the procedure.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 12dec2016.During troubleshooting activities by merge technical support and the customer, the customer further reported that when trying to print a study at the end of a procedure the client pc locked up and a critical error was displayed on the monitor.Merge technical support reviewed the event logs and found three (3) different unhandled exception errors.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).At the time of the customer's initial call to merge technical support, their hemo software version was 9.40.1.The site was upgraded to hemo v9.40.3 patch 1 on 05feb2017 ((b)(4)).The release notes state, "improvements have been made to error handling to prevent the application from closing unexpectedly." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the site's software upgrade that addresses the reported issue.Revised information contained in this supplemental report includes the following: g7 - indication that this is follow-up report 001.H6 - evaluation codes: method code #1: 3372 analysis of data logs.Method code #2: 3273 code review (a systematic review of source code intended to find and fix mistakes possibly overlooked in the initial development phase).Results code: 637 unhandled interrupt or exception (the device software did not correctly address abnormal execution of the code).Conclusions code: 12 design deficiency (the device problem was traced back to the design specifications (e.G.In the requirements, testing processes, hazard analysis, implementation strategy).H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6183801
• MDR Text Key: 62794686
• Report Number: 2183926-2016-00819
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

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
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 02/14/2017
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1