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

Model Number	MERGE HEMODYNAMICS 10.0.4 PATCH 1
Medical Device Problem Codes	Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting from hemo support on (b)(6) 2018 found a client/server session failed error.A replacement hemo pc was sent to the customer on (b)(6) 2018 and the replacement hemo pc was installed.The results of the returned hardware evaluation found that the customer's allegation of network connection issues could not be duplicated.Troubleshooting from hemo support on (b)(6) 2018 found no communication between the client pc and the hemo pc.However, there was no indication as to why communication was lost.The customer was able to restart the hemo system to resolve the connection issues.Further follow up with the customer a week later determined that no further connection issues were noted.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Per hemo-6373 merge hemo 10 user manual: page 54: communication.Record station.When a command is issued by touching or clicking an icon on the client pc, the hemo monitor pc responds.Physiologic monitoring is accomplished by these two computers joined via unique communication protocols.There are three icons on the bottom of the hemo monitor, left of the time display, that are displayed as visual indicators of system status.The patient name is displayed at the top of the screen and the day, date, and time are displayed at the bottom of the screen.(person) this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm).If there is a problem with any of the functions represented by the above three images, the icon color will switch to red.
Event or Problem Description
Merge hemodynamics displays, 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) 2018, the customer contact reported that the client pc and the hemo pc lost connection to one another in lab 3.It was reported that the patient was moved to another lab, however, it is unknown if this occurred prior to the start of the case or during.On (b)(6) 2018, the customer further reported that the client pc and the hemo pc lost connection again during a case, while the patient was already sedated.As a result, the hemo system was rebooted and the case was completed once hemo came back online.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7695305
• Report Number: 2183926-2018-00062
• Device Sequence Number: 11016731
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K082421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1