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

Model Number MERGE HEMODYNAMICS 9.40.1

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

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the customer's hemo case management within merge healthcare's internal database found that the reported freezing issue has been an ongoing problem at the site.All hardware and cabling have recently been replaced with the exception of the hemo monitor.Merge healthcare concluded that this hardware should also be replaced so a new unit (b)(4) was shipped to the customer on (b)(6) 2017 that contained a new brand of cyber serial card (b)(4).The faulty unit was returned to merge healthcare on aug 22, 2017.The results showed that unit had a (b)(4) serial card installed.(b)(4) serial cards have been found to cause connection issues in the past, so it was replaced with a (b)(4) brand serial card.The drives on the faulty unit were wiped, the unit was reloaded with software, the unit passed all diagnostic testing, and it ran for five (5) days without issue.The unit was then sent to service stock.An internal investigation ((b)(4)) found that the (b)(4) serial cards have caused connection issues in the past at some customer sites.In order to proactively eliminate this issue, any hemo monitor that is returned with an outdated serial card will be replaced with (b)(4) brand cards.It was also found that the customer was on an outdated version of merge hemodynamics so technical support upgraded the site to hemo v9.40.3 patch 1 as well as updated the firmware on the site's pdm's (patient data modules).(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 froze during a procedure.The medical staff rebooted the hemo system that resulted in a loss of patient monitoring.Information obtained from the customer revealed that the procedure was paused/stopped while the medical staff waited for the hemo system to reboot and it was noted that the non-emergent patient had already been sedated.The customer further stated that, in their opinion, there was no injury or adverse effect to the patient during this time.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could result in harm to the patient.The procedure was completed successfully once the hemo system was rebooted.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 15sep2017.During documentation review activities conducted by merge healthcare on 16may2018, it was found that the initial report was submitted with conclusion code 11 (conclusion not yet available-evaluation in progress); however method, result, and conclusion codes were included in the h10 narrative initial report as well as troubleshooting efforts performed by merge healthcare for the customer's reported problem.Therefore, this supplemental report is being submitted with only the applicable method, result, and conclusion codes as all other previously reported information remains the same.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6867785
• MDR Text Key: 86413955
• Report Number: 2183926-2017-00179
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

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 9.40.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1