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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

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

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

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting with hemo support determined that hemo monitor setting in system management did not have hemo monitor selected.Once this setting was corrected in system management, the flashing red arrows were gone and hemo was functioning as expected.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Additionally, this event is typically recognized prior to the start of a case when the user is setting up equipment.The merge hemo user manual includes a guide on the communication between the pdm and the hemo monitor pc, equipment care guide, and tips on frequently asked questions.Per hemo-6373 merge hemo 10 user manual: (p.54) communication record station when a command is issued by touching or clicking an icon on the client pc, the hemo monitor pc responds.Physiologic monitoring is accomplished by these two computers joined via unique communication protocols.There are three icons on the bottom of the hemo monitor, left of the time display, that are displayed as visual indicators of system status.The patient name is displayed at the top of the screen and the day, date, and time are displayed at the bottom of the screen.(person) this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm).If there is a problem with any of the functions represented by the above three images, the icon color will switch to red.(p.365) 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.

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.A customer contacted merge healthcare technical support and reported that on (b)(6) 2018, during an electrophysiology (ep) study, the people/person icon started flashing red indicating a communication issue with the patient data module (pdm).The hemo monitor pc was rebooted a couple of times during the case with no resolution.The patient was previously connected to anesthesia monitoring equipment therefore, medical staff were never without the ability to correctly monitor the patient's non-invasive vital signs.No invasive pressures were being monitored for this patient.There was no indication of patient harm as a result of this issue and the case was completed with no incident.However, 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.(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: 7530970
• MDR Text Key: 109370507
• Report Number: 2183926-2018-00043
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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