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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problem Application Network Problem (2879)

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

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

It was found during troubleshooting efforts that the customer's reported problem affected two (2) related sites because they share the same server.However, the procedures in progress prior to this issue were not affected.The hemo users could not open or create a new study, so the site decided to cancel the remaining scheduled/elective procedures and activate their stemi divert plan.Only one (1) procedure was directly affected by this issue and the procedure was completed successfully.An internal investigation is underway (hemo-11038) and it was determined that the cause of the problem occurred when a site hemo user made changes to the hemo system config that affected the procedure documentation/reporting templates component.Merge healthcare has corrected the customer's templates component so that future occurrences do not occur.To date, no other customers have been identified with this issue.Device labeling, hemo-5303 v9 user manual, addresses the potential for such an occurrence by statements such as, "caution: system config should be managed by trained support personnel or the site administrator." (b)(4).

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 august 29, 2017, a customer reported to merge healthcare that a critical error occurred on the client pc during a coronary stent placement procedure.Subsequently, the hemo monitor and client pc were both rebooted causing a loss of physiological monitoring and patient data capture.Information obtained from the customer revealed that upon reboot, the client pc did not function as intended but the hemo monitor was capturing the patient's invasive pressures.The medical staff employed manual charting of the invasive pressures during the procedure while a portable monitoring device was used to capture the patient's vitals.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully through the combined use of merge hemo, a portable vitals monitor, and manual charting.(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: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6899801
• MDR Text Key: 88074018
• Report Number: 2183926-2017-00180
• 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
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1