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

Model Number MERGE HEMODYNAMICS 9.40

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare conducted an internal quality investigation to address this issue that has been previously reported in recall (b)(4), fda recall number (b)(4).Merge healthcare received reports of the hemo monitor application unexpectedly stopping to display and update patient data.When this issue occurs, the hemodynamics system is no longer capturing patient data.For customers who experience this issue, it is recommended that the hemo monitor pc is power cycled.Once the system is powered up, the hemo application should restart with normal functionality and will once again display, update and record patient data.The restarting of the hemo monitor pc may result in a delay of up to two minutes while the system reboots.The investigation and troubleshooting activities conducted by merge healthcare found that the issue occurred due to an error when interfacing with a specific location within a schiller pdm (patient data module) file.Merge has validated and released a firmware fix for this issue.This fix is incorporated into the software upgrade of merge hemo 9.40.3 patch 1 (or later), or merge hemo 10.0.3 patch 1 (or later).The correction has been verified to be effective as is evidenced through the large reduction of customer complaints concerning this issue.This event occurred due to the customer remaining at hemo v9.40 after the recall notification was sent to the customer on 29mar2016.There have been no responses to that notification and subsequent follow ups.Tech support will contact the customer to schedule the needed upgrade to hemo v9.40.3 patch 1 which corrects the issue.Once the upgrade had occurred and confirmed functional, a supplemental report will be submitted.(b)(4).

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) 2019, a customer reported to merge healthcare that the hemo monitor was intermittently shutting down on its own and it had occurred a couple of times recently.Information obtained from the customer revealed that one occurrence was during a procedure.The hemo monitor was rebooted/power cycled and the issue was readily corrected.The other occurrence happened prior to a procedure starting.No date for the first event was provided, so the date captured of this report is the date the customer called in to report the issue.With merge hemo not presenting physiological data during treatment, there is a potential for delay in treatment that could result in harm to the patient.However, the customer confirmed that the issue was resolved after a reboot of the hemo monitor.Reference complaint (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 21feb2019.After multiple attempts to contact the customer and rescheduling the upgrade due to last minute site cancellations, merge healthcare technical support successfully upgraded the site to hemo v9.40.3 patch 1 on 07nov2019.It was confirmed that the software is functioning as expected.No further actions by merge healthcare are anticipated at this time since the resolution to the issue identified fda recall number z-0665-2017 is a firmware fix incorporated into the software upgrade of merge hemo 9.40.3 patch 1 (or later).Revised information contained in this supplemental report includes the following: date new information received by manufacturer (site software upgrade date) 11/07/2019.Evaluation codes: methods: 3331 analysis of production records.Results #1: 104 software problem identified.Results #2: 110 design error.Results #3: 113 interface design error.Conclusions code: 12 cause traced to device design.Indication of additional manufacturer information and corrected data are 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: 8360058
• MDR Text Key: 136854942
• Report Number: 2183926-2019-00005
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0665-2017
• Patient Sequence Number: 1