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

Model Number MERGE HEMODYNAMICS 9.40.1

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 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

Replacement hardware, a patient data module (rma #(b)(4)) and a hemo monitor pc (rma #(b)(4)), was shipped to the customer on 14feb2017.As of 08mar2017, only one (1) of the faulty units has been returned to merge healthcare for evaluation.For this reason, conclusions code 11 (conclusion not yet available-evaluation in progress) was used.When the results for both of the faulty units are 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) 2017, a customer reported to merge healthcare that problems were experienced with the hemo monitor freezing twice in the middle of a procedure after active monitoring had been initiated.Subsequently, the hemo monitor was rebooted twice and resulted in a loss of patient monitoring.The delay was ~2 minutes for each occurrence while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted the second time.(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 14mar2017.As stated in the initial report, replacement hardware - pdm (patient data module) and hemo monitor were shipped to the customer on 14feb2017.The pdm was not returned by the customer for evaluation.The hemo monitor was returned to merge healthcare on 20feb2017 for evaluation.The results showed that the siig serial card was replaced with a lava brand card, software was reloaded, the unit passed full system diagnostic testing, and it ran for four (4) days without issue.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).An internal investigation ((b)(4)) found that the siig serial cards have caused connection issues in the past at some customer sites.In order to proactively eliminate this issue, any hemo monitor that is returned with an outdated serial card will be replaced with lava brand cards.The customer confirmed that the replacement hardware corrected the reported issue.In addition, a review of the customer's hemo case management within merge healthcare's internal database found that the site has not called in again for any similar issue since their initial call on 14feb2017.No further actions are anticipated at this time due to the issue being readily apparent to the user and the non-serious impact to a patient.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 10 actual device evaluated.Results code: 628 communications problem (devices that do not send or receive adequate signals).Conclusion code: 13 device difficult to operate.H10 - 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: 6405042
• MDR Text Key: 69956042
• Report Number: 2183926-2017-00060
• 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: 02/14/2017

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 9.40.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1