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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Use of Incorrect Control/Treatment Settings (1126); Application Program Problem (2880)

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

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Merge technical support worked with the customer to troubleshooting the issue.It was found that windows defender was actively running on the entire hemo system and caused a loss of communication between the hemo server and client pc.Once windows defender was deactivated, the workstation began to replicate with the hemo server, which allowed access and use of the interface, and corrected the customer's reported issue of grayed out chrono-log tabs.Merge hemo has labeling that includes product security recommendations.This documentation addresses the potential for this issue with statements such as, "merge healthcare recommends that the windows firewall service be disabled on the merge hemo server, cath lab clients, and ancillary workstations.The windows firewall has caused communication problems and poor performance between the merge hemo server and connected workstations.To accomplish this, the anti-virus software needs to be configured to scan only the potentially vulnerable files on the system, while skipping the medical images and patient data files.Our experience has shown that improper configuration of anti-virus software can have adverse effects including downtime and clinically unusable performance." device labeling for hemo v10 includes equipment usage restrictions with statements such as, "do not load any software onto the hard drive as it may corrupt the system software.Only authorized service personnel should load software onto system components." a review of the customer's hemo case management within merge healthcare's database confirmed that the customer has not reported this issue or similar issue to date.No further action by merge healthcare is anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the customer's confirmation that the issue was resolved by deactivating the site's anti-virus software on the specified files.(b)(4).

Event Description

Merge hemodynamics displays, 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) 2020 a customer reported to merge healthcare that the chrono-log tabs were grayed out in the hemo application user interface.The chronlog is the portion of the application where patient and procedure data are recorded and is used by the application to create the patient's study report.Clinical staff elected to move the patient to another onsite lab after sedation had been administered, rather than continue the procedure in the current lab with the chrono-log's tabs grayed out.With merge hemo not capturing physiological data during treatment, there is a potential for delay in treatment that could result in harm to the patient.However, the customer reported that the procedure was completed successfully and there was no adverse effect to the patient.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• Manufacturer Contact: brian bell ; 75 binney street; cambridge, ma ; 3540189
• MDR Report Key: 9788181
• MDR Text Key: 188865434
• Report Number: 2183926-2020-00008
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1