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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Merge technical support shipped replacement hardware, a hemo pc fru (rma #13411), to the customer on 15nov2017.The customer returned the faulty unit to merge healthcare on 20nov2017 for evaluation; however the evaluation results are not available as of 06dec2017.For this reason, (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 pc in the site's cath lab 1 began to smoke and smelled of burning rubber.It was also reported that there was no patient involvement, and there were no reports of harm to the staff due to this issue.With a smell/gas being emitted from an electrical component, there is a potential for little to no impact to those breathing in the smell to a potential for harm.The customer has not reported any ill effects as a result of exposure to the smoke and or resulting smell.(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 12dec2017.As stated in the initial report, a replacement hemo pc fru was shipped to the customer on 15nov2017.The faulty unit was returned to merge healthcare on 20nov2017 for evaluation (rma #(b)(4)).The results showed that the customer's reported problem, unit smoking and smelled of burned rubber, was not found.Further, the unit functioned as intended and booted up with no issues and passed full system diagnostic testing.However, as a precautionary measure due to a previously conducted internal investigation (hemo-6542), the cyber serial card was replaced with a lava brand serial card, because it was found that older 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 lava brand cards.A review of the customer's hemo case management within merge healthcare's internal database found that the site has not called in again for any reason since reporting this issue on 14nov2017.No further actions are anticipated at this time due to the issue being readily apparent to the user and no risk to a patient since there was no patient involvement when the issue occurred.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 10 actual device evaluated.Results code #1: 213 no failure detected [used for customer's allegation] results code #2: 3213 interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components) [used for serial card replacement].Conclusion code #1: 71 no failure detected, device operated within specification [used for customer's allegation].Conclusion code #2: 13 device difficult to operate [used for serial card replacement].H10 - indication of additional manufacturer information is contained in this follow-up report.

• 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: 7109204
• MDR Text Key: 95804974
• Report Number: 2183926-2017-00210
• 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: 11/14/2017

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 9.40.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1