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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting with hemo support, flashing arrows were noted.Hemo support walked the customer through the process of rebooting the hemo system correctly: shutting down the hemo pc and then the client pc.Once both hemo pc and client pc were shutdown, the client pc was rebooted.The customer waited until it got to the windows sign on page, then the hemo pc was rebooted.Once the hemo pc was up, the client pc was logged into the hemo application.The hemo pc and client pc were reconnected.This issue is related to an investigation, (b)(4): hemo monitor does not connect to the client if the client is not powered up before the hemo monitor.Per the investigation: the work around is to always power up the client first.Once the client is powered up, reboot the hemo monitor.The cause of this issue is that the network card is not able to be bound to as it does not have a valid a ip address.This is even if the card has a fixed ip address.This issue will be resolved in a later version of hemo: version 10.2.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Per (b)(4) merge hemo 10 user manual: (page 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.(arrow icon) this icon appears to indicate communication between the hemo monitor pc and the client pc.If there is a problem with any of the functions represented by the above three images, the icon color will switch to red.(page 355.) problem: there is no communication between hemo monitor pc and client.Resolution: check that the crossover cable from the client to the hemo monitor is plugged in properly and lights are on.Reboot the hemo monitor pc.Exit and reopen the study.Answer yes to is patient still being monitored.Check that the client is properly configured to use the hemo monitor pc (in system config).If none of these work, 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.On (b)(6) 2018, the customer contact reported that cath lab 2 was having connectivity issues which was noted by flashing arrows.It was reported that this occurred prior to the start of a st-elevation myocardial infarction (stemi) case, however the patient was already sedated and being actively monitored.As a result, the hemo monitor pc was rebooted and the case was completed once hemo came back online.In addition, the patient's heart rate (hr), rhythm, and blood pressure (bp) was captured using a 3rd party monitoring device.With merge hemo not capturing physiological data, there is a potential for incorrect treatment and/or 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: 7775819
• MDR Text Key: 117287988
• Report Number: 2183926-2018-00072
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• 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