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

Model Number MERGE HEMODYNAMICS 10.0

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.For this reason, conclusions code 11 (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 the hemo monitor display went blank during a procedure and required the system to be rebooted.With merge hemo not presenting physiological data during treatment, there is a potential for a delay diagnosis or treatment that may result in harm to a patient.However, the customer stated that the procedure was completed successfully using an alternative monitoring device.(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 18aug2016.During documentation review activities by merge healthcare, it was determined that the cause of the customer's reported problem, client pc went blank during a procedure, 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 healthcare technical support remotely accessed the site's hemo server and found the following error messages in the application log: group policy object did not apply because it failed with error code '0x80070002 the system cannot find the file specified.' failed to process policy info.Error details: "the system cannot find the file specified.Device labeling, hemo-6377 merge hemo v10 domain integration, addresses the potential for such an occurrence with statements such as, "block group policy inheritance for the merge hemo ou (organizational unit).This protects the system nodes from possible adverse effects from a facility-wide group policy.To block group policy inheritance, create a new group policy object for the merge hemo ou and select the block policy inheritance check box.Only these serviceability and application accounts should be placed in the merge hemo ou: merge hemo users, merge hemo admin users, merge hemo database administrators, merge hemo database users, merge hemo export users, merge hemo report users." the hemodynamics system is designed with a hemo monitor and a client pc that are separate units that operate independently of one another.When there is a problem with the client pc, patient data continues to display on the hemo monitor.Since this issue occurred on the client pc, the medical staff had the option to manually chart the patient's data and then add it to the chronlog within the hemo application at a later time.However in this instance, the medical staff chose to use a third party monitoring device.Based on the information described above, conclusions code 19 (human factors issue) was used.Revised information contained in this supplemental report includes the following: 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: 19 human factors issue.Removed checked radio buttons for recall and notification (correction).Removed recall number (correction).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: 5887884
• MDR Text Key: 52612051
• Report Number: 2183926-2016-00692
• 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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2183926-02/15/2016-031-C
• Patient Sequence Number: 1
• Treatment: PHILLIPS TRANSPORT MONITOR