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

Model Number MERGE HEMODYNAMICS 10.0

Device Problems Failure to Cycle (1142); Device Issue (2379); Calibration Problem (2890)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare (hemo-8794).For this reason, conclusions code (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 issues were experienced with a third party ffr (fractional flow reserve) device and its interaction with merge hemo.The available information indicates that a reboot of the merge hemo application occurred during an active case that may have resulted in a brief lapse of patient monitoring and may have caused the procedure to be delayed for a short period time; however, several attempts have been made to obtain additional event information from the customer with no success.Therefore, merge healthcare is conservatively reporting this event.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, the customer did not report or allege that any serious injury or death occurred as a result of the reported problem.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted (b)(6) 2016.Merge healthcare conducted an internal investigation and it was found that when the user had an issue with the nibp feature, a manual reset was done.When this occurs, all of the calibrations for the cables/instrumentation is nullified and the customer, per the user guide, is required to re-calibrate their instrumentation/leads.The hemo monitor pc is expecting continuous signals and is not aware that the pdm has been reset.Therefore, the customer would need to calibrate the pressure channel to notify the hemo pc that a change has occurred and previous settings/calibrations are invalid.After the pressure channel has been calibrated the user then selects the desired ecg signal for analog output and then will re-select the desired pressure channel.Device labeling, user guide hemo 10.0, addresses the potential for such an occurrence in frequently asked questions: question: why does the system go to not calibrated (nc on the pressure channels) when the transducer is disconnected, even if the same one is reconnected? answer: as soon as the transducer is unplugged, the pdm cannot know that the same one is being reconnected.The pdm performs an automatic calibration if the transducer is open to air at the time that it is plugged in.The nc notation only goes away when a calibration is performed in the study.The device labeling was enhanced and has been documented in hemo v10.0.4 release notes making users more aware of the potential issue: "if the pdm is manually reset, the analog output will not transmit a signal.The channel must be recalibrated and redefined on the settings folder's analog output tab.Refer to the settings chapter of the merge hemo user manual for more information." revised information contained in this supplemental report includes the following: updated contact office - name/address.Date new information received by manufacturer (case closure date).Indication that this is follow-up report 1.Indication of malfunction as reportable event.Indication that the follow-up report is due to additional information and device evaluation.Added device manufacture date.Evaluation codes.Method code: 20 - interoperability evaluation (testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components).Results code: 444 - user interface.Conclusions code: 19 - human factors issue.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: 5728238
• MDR Text Key: 47493642
• Report Number: 2183926-2016-00607
• 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
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

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 10.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: 07/25/2016
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VOLCANO FFR DEVICE; VOLCANO FFR DEVICE