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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

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

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

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

Merge technical support reviewed the event logs and did not find any error regarding a server disconnect or a hemo monitor error.It was believed that the serial lava card was faulty.Merge technical support shipped the customer a replacement hemo monitor pc (rma #12910) on 15aug2017.The faulty unit was returned to merge healthcare on 22aug2017 for evaluation.The results showed that the video card was dropping - there was no video after five (5) minutes of use.The video and lava cards were then replaced.The hard drive was wiped, reloaded with software, passed all diagnostic testing, ran for five (5) days without issue.It was confirmed that the issue was resolved with replacement hardware.Follow-up with the site's contact did not have information pertinent to the other occurrences.The customer contact sent the request for information to the involved department.If/when more information becomes available, a supplemental report will be submitted with the new information.Device labeling, hemo-6373 v10, addresses the potential for such an occurrence with statements such as, "check the server for errors - front lights / indicators, audible alarms, and openmanage (if applicable).Log on to openmanage 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 openmanage and close the browser;" and "check the event logs for errors and warnings." (b)(4).

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) 2017, a customer reported to merge healthcare that the hemo monitor disconnected from the server while a patient was on the procedure table.Subsequently, the medical staff rebooted the hemo monitor resulting in a loss of patient monitoring.The customer further reported that this issue has occurred several times, however the exact dates and procedure outcomes are unknown at this time.This known occurrence has been reflected in , date of event.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could result in harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.(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: 6857229
• MDR Text Key: 86008264
• Report Number: 2183926-2017-00177
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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