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

Model Number MERGE HEMODYNAMICS 9.40.3 PATCH 1

Device Problems Failure to Cycle (1142); Blocked Connection (2888); Data Problem (3196)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem was internally investigated by merge healthcare (b)(4).The system is designed to allow users to lock a study or tab within the study to make changes.This ensures that two users cannot make changes to the same study at the same time.However, in some instances the system will lock tabs within a study even when a second user does not have the study open on a different workstation.This "phantom" lock mimics the described behavior except the lock is not caused by a second user but by the sql table.Because data is written to the local database in this version, an additional check by the software is made to ensure that the locking data is the same on the server before freeing the lock.When a hemo client loses connection to the hemo server, any locks that the client had at the time will remain until that client is able to replicate its data to the server.This results in the inability for the user to be able to edit data for those tabs and chronological log entries.The problem is resolved when the locks are cleared in the structured query language (sql).Merge healthcare has identified this as an issue and has executed a recall to address this as a potential risk due to delay in treatment.This phantom locking issue has been corrected in hemo 10.0 software release.The customer is aware of the issue and understands that the correction is to upgrade their version of hemodynamics.

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 locks appeared on several tabs in the hemo application at the start of a procedure.This prevented the user from entering patient data and briefly delayed the procedure.The affected tabs included the patient/data study, pre-procedure, and hemodynamics.Depending on which tab is locked, it could prevent a calculation from computing correctly if the patient's data, such as height and weight, are in a locked state.It could also prevent the patient study from promptly being confirmed.This could pose a potential risk to the patient caused by a delay in treatment.However, it was confirmed that merge healthcare quickly resolved the problem by accessing the sql (structured query language) and resetting the locked tabs so that they became editable after replication.There was no report of risk of serious injury to the patient because of the locked tabs.To date, merge healthcare has not received any allegations of a serious injury or death because of this reported problem.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6401680
• MDR Text Key: 69869897
• Report Number: 2183926-2017-00067
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• 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 PATCH 1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-048-C
• Patient Sequence Number: 1