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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts between the customer and merge technical support, the customer was instructed to push the emergency stop button on the front of the pdm (patient data module) after the first procedure was completed.Further instruction was to ensure that all cables were secure and then reboot the client pc and hemo monitor in the proper sequence.The customer followed the instructions and upon reboot the arrow icon was flashing indicating a disconnection between the hemo monitor and client pc.A second reboot corrected the issue.Information obtained from the customer confirmed that the second occurrence did not affect an ongoing procedure.Device labeling, hemo-6373 v10 user manual, addresses the potential for a loose cable connection in the troubleshooting section with statements such as, "problem: there is no full disclosure recording.Resolution: close the study and exit the application.Power down and reboot both the client and hemo monitor pcs.Reopen the study.Answer yes to "is patient still being monitored." if problem persists, contact technical support.(b)(4).Methods code: actual device evaluated.Results code: interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components.) conclusions code: device difficult to operate.

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) 2018, a customer reported to merge healthcare that the person icon located within the hemo application was flashing red indicating a disconnection between the hemo monitor and pdm (patient data module).This occurred during a procedure and full disclosure recording was not available.It was further reported that vitals could not be recorded for the procedure, and the medical staff used cardiolab recording system to capture the patient's images.Additional information obtained from the customer revealed that the problem occurred twice on the same day; however only the first procedure was affected and the second procedure was not since it had not yet started.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully by using third party equipment.Reference complaint-(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: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 7445809
• MDR Text Key: 106146867
• Report Number: 2183926-2018-00022
• 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: 03/21/2018

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 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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