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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Application Program Problem (2880); Blocked Connection (2888)

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

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by (b)(4) healthcare.For this reason, conclusions code (conclusion not yet available-evaluation in progress) was used.When more information becomes available, a supplemental report will be submitted.

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) 2016, a customer reported to merge healthcare that problems were experienced in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring.The delay was approximately 10-15 minutes while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.Reference complaint number (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 29dec2016.During troubleshooting efforts between the customer and merge technical support, the customer reported that the hemo monitor was rebooted in the site's cath lab 2 and this corrected the issue.The procedure in progress was completed successfully in this same lab.However, the customer called in two (2) subsequent times to report a similar issue in the same lab.Reference (b)(4) and (b)(4).A review of the customer's hemo case management within merge healthcare's internal database on (b)(6) 2018 confirmed that there have been no further issues reported by the customer to merge healthcare concerning an issue requiring a reboot of the hemo monitor since the last occurrence cited above.Device labeling, hemo-6373 v10 user manual, addresses the potential for a loose cable connection in the troubleshooting section with statements such as, "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." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious injury assessment to a patient, and the instructions provided to the user on what to do if this situation were to occur.Revised information contained in this supplemental report includes the following: g1-2 - updated contact office - name/address.G4 - date new information received by manufacturer (case closure date).G7 - indication that this is follow-up report 1.H1 - indication of malfunction as reportable event.H2 - indication of additional information and device evaluation.H6 - evaluation codes: methods code: 3263 - actual device not evaluated.Results code: 3213 - interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components).Conclusions code: 13 - device difficult to operate.H10 - 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: 6214996
• MDR Text Key: 63616072
• Report Number: 2183926-2016-00826
• 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: 11/10/2016

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 10.0.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: 02/10/2017
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1