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

Model Number	MERGE HEMODYNAMICS 10.0.4 PATCH 1
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting activities included shipping the customer a replacement hemo monitor on (b)(6) 2018.The faulty unit was returned to merge healthcare on (b)(6) 2018 for evaluation.The results confirmed that the unit would not power on.A replacement power supply was received from dell and installed.The hard drive was wiped of phi (protected health information) and replaced with a new one.Software was loaded and the unit ran for two (2) days without issue.The unit was further tested according to hemo-11245 and passed; it was then returned to service stock.Once the replacement hardware was received, installed, and properly configured with the site's current version of hemo (10.0.4 patch 1), the customer confirmed the unit functioned as intended.A review of the customer's hemo case management within salesforce on (b)(6) 2018 confirmed that the customer has not called in again regarding any similar hemo monitor hardware issues.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Additionally, a low number of customers have reported this issue therefore reducing the frequency of occurrence.In addition, this is the first reportable occurrence involving a power cord issue.No further actions are anticipated at this time due to the issue being readily apparent to the user, the low number of complaints, and the non-serious injury to a patient.(b)(4).
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, a customer reported to merge healthcare that a power issue occurred in the middle of a procedure resulting in the loss of capturing physiological data.The customer reported that both the hemo monitor and client pc were rebooted; afterwards the hemo monitor would not power on.Subsequently, third party monitoring was used, however the brand/type was not disclosed to merge healthcare.It was also reported that there was a slight delay while connecting the external equipment.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, it was reported that the procedure was completed successfully using third party equipment.Reference complaint- (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: 7643364
• Report Number: 2183926-2018-00055
• Device Sequence Number: 16532885
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: (01)00842000100010(10)10044395(11)170301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1