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

Model Number MERGE HEMODYNAMICS 9.30

Device Problems Computer Software Problem (1112); No Display/Image (1183); Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 02/04/2016

Event Type  malfunction  

Event Description

Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the 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 hemo monitor pc via the serial interface.The transmitted patient data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the hemo monitor stopped functioning towards the end of a catheterization procedure.A loss in monitoring a patient's hemodynamic information during a procedure could lead to a delay in treatment; however, the customer did confirm that the patient's treatment was not delayed and the procedure was completed successfully by alternate means.

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 06mar2016.During documentation review activities by merge healthcare, it was determined that the cause of the customer's reported problem, client pc in the site's cath lab 2 frequently offline, was not a result of the issue identified recall 2183926-02/15/2016-031-c, fda recall number z-0665-2017, as initially reported to the fda.Merge technical support found hanging spid's (server processor id's) in the structured query language (sql) for that unit.The processes were terminated and then replication was ran so that automatic synchronization would occur.Information received from the customer confirmed that the problem occurred after the procedure was completed successfully and while the patient was in holding.The patient's vitals were captured using a portable defibrillator and manual charting was used to add the information into the chronlog within the hemo application.It was found that the reported issue affected only the client pc.It was confirmed by follow up information obtained from the customer since the client pc and hemo monitor pc are separate units that operate independently of one another, the patient's data was still displayed.Therefore, the initial report was filed in error since there was no potential for data loss.Device labeling, hemo-5303 v9 user manual, addresses the potential for such an occurrence with statements such as, "ancillary workstations may be managerial, physician, or holding / recovery.Ancillary workstations offer access to the application for functions of patient studies outside of the catheterization lab.Such functions include entry of patient data, the monitoring of patient vitals pre and post procedure, the creation and printing of study reports, and the management of equipment inventory and system configurations." h6 - evaluation codes: methods code: 20 - interoperability evaluation.Results code: 3210 - deadlock (the device software locked up because two or more processes were waiting for each other to finish.) conclusions code: 13 - device difficult to operate.H7 - removed checked radio buttons for recall, notification, and patient monitoring (correction).H9 - removed recall number (correction).H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5482745
• MDR Text Key: 39755290
• Report Number: 2183926-2016-00455
• 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: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

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 9.30
• Device Catalogue Number: 9.30
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/06/2016
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2183926-02/15/2016-031-C
• Patient Sequence Number: 1