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

Model Number MERGE HEMODYNAMICS 10.0.3

Device Problems Failure to Transmit Record (1521); Data Problem (3196)

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

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support provided assistance for the customer to troubleshoot the reported problem.Errors were found that were related to the video driver.A "clean install" was completed for the video driver.However when follow up was done by merge, event log entries for stop errors and network hardware events were found.Technical support requested that the site replace the network card.The customer confirmed that replacing the network card was successful and the hemo system functioned correctly.The hemo user guide, addresses the potential for such an occurrence with statements such as, "check the server for errors - front lights / indicators, audible alarms, and open-manage (if applicable).Log on to open-[manage using local server administrative credentials.Check the health list on the properties tab.All items should have green checkmarks beside them.If a red x is present, contact merge healthcare customer support.Log off from open-manage and close the browser;" and "check the event logs for errors and warnings.".

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 monitor shutdown during a procedure.Information obtained from the customer revealed that a patient was disconnected from active monitoring while sedated that resulted in approximately a 5 minute delay.It was further stated that "paper charting and the use of a phillips monitor" was used to complete the procedure.With merge hemo not presenting physiological data during treatment, there is a potential for delay in treatment that results in harm to the patient.However, the customer reported that the procedure was completed successfully.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5908645
• MDR Text Key: 53294975
• Report Number: 2183926-2016-00697
• 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: 07/26/2016

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 10.0.3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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