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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH1

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting from merge hemo technical support determined that the customer's network/it had a group policy where (b)(4) scans were occurring during the day.These scans coincide with the event/error logs that indicated the system was not able to connect to the server and went into local mode (8:13-8:15am on (b)(6) 2018) and had a high replication time.A technician was dispatched to troubleshoot the issue on-site.Fuses were replaced and the technician re-checked all cabling and connections, booted both pc's, and while the remote access/connectivity was slow, merge healthcare support was then able to remote into the customer's system and pull up hemo as expected.However, after pulling up a test case, an error was received that the database connection was disabled and hemo was functioning in local mode.To ensure a complete investigation of the customer's allegation, merge technical support shipped replacement hardware ((b)(4)) to the customer.The customer's hemo pc that was in use when database connectivity became and issue, was returned to merge healthcare by the for further evaluation.The unit has not yet been received.Therefore conclusion (#11) was selected as the investigation is not yet complete.

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.The customer contacted merge healthcare technical support and reported that on (b)(6) 2018, the two people icon was flashing, indicating a communication issue between the hemo monitor pc and patient data module (pdm), and the scale was not allowing adjustments.This was noted during charting after a case was already completed.However, on (b)(6) 2018, the red heart was transitioning from red to grey during cases, forcing the users to power cycle the hemo monitor pc multiple times.With merge hemo being rebooted and not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.There were no reported adverse events.However, if additional information is received from the customer, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

The hardware evaluation results of the hemo pc found that the cause could not be duplicated.The repair engineer did find a loose part in the video card standoff, which was replaced.The customer's alleged database connection issues were either due to a bad network jack or configuration issue.The repair engineer wiped and reloaded hard drive and ran antivirus.The unit ran for three days with any network problems.The unit also passed full system diagnostics and was returned to stock.The potential impact to a patient has been reviewed and the severity level has been assessed as medium (non-serious injury).Per hemo-6373 merge hemo 10 user manual: (page 55): the color of the icon indicates the status of communication between the client and server.Red indicates communication between the client and server.If this icon is grayed-out, communication between the client and server has been interrupted.When this icon turns gray, a message will appear on the screen.While this icon is grayed-out, do not run any of the external applications in the application bar.When the client is offline from the server, and the workstation is an always connected workstation, work can be done in local mode.Workstations synchronize with the server automatically when a stable connection is restored.If work had been done on more than one workstation in the same folder, the study will recognize the workstation with the most recent timestamp.(see the operations chapter for a complete explanation of concurrent access.) only record stations are installed as always connected.When the client is offline from the server, and the workstation is a direct connect workstation, the application will close.No data entry will be allowed until the server connection is available and the user restarts the application.Revised information contained in this supplemental report includes the following: evaluation codes: methods code: 10 - testing of actual/suspected device.Methods code: 22 - software evaluation.Results code: 3213- interoperability problem identified, 4205- network communication problem, 104- software problem identified, 3208- configuration issue.Conclusions code: 12 - cause traced to device design, 4302- human factors engineering- device difficult to operate.

• 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: 7497489
• MDR Text Key: 107829944
• Report Number: 2183926-2018-00034
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• 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 PATCH1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1