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Model Number MERGE HEMODYNAMICS 9.40.3
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2017
Event Type  malfunction  
Manufacturer Narrative
Client pc reported issue: during troubleshooting efforts by merge technical support through remote access to the customer's client pc workstation, the event logs were reviewed and a "\device\harddisk0\dr0" error message was found. Merge technical support then performed a "check disk scan. " a subsequent review of the event logs found that the error message was no longer displayed and the problem corrected. During a scenario such as this involving the client pc, the hemo application is designed to allow the user the ability to manually chart a procedure and then enter the information into the chronlog at a later time to prevent the loss of patient monitoring and/or data. As evidenced by the device labeling hemo-5303 v9 user manual, it states, "when the client is offline from the server, work can be done in local mode. Workstations synchronize with the server automatically when a stable connection is restored. If work had been done on more than one workstation in the same folder, the study will recognize the workstation with the most recent timestamp. " however, since there was also a connection issue between the pdm and hemo monitor due to a faulty trunk cable, patient data could not be captured. For this reason, conclusions code 18 (failure to follow instructions) was used and is explained below. Pdm reported issue: during a previous event at the site with a similar issue ((b)(4)), it was found that the customer altered the mounting position of the pdm causing connection issues. (reference mdr #2183926-2017-00157. ) merge technical support has advised the customer not to configure the pdm and trunk cable in this way because it puts undue stress on the cable and ports; however, the site continues use the equipment in this manner. When merge technical support inquired with the customer about installation of the replacement trunk cable on (b)(6) 2017 from their previous call-in, it was stated that it had not yet been installed. However, on 18jul2017, the customer called merge technical support to inform them that the reported issues had been resolved indicating that the trunk cable had eventually been installed and confirmed working correctly. During this conversation, the customer asked about another trunk cable and they were directed to merge healthcare's estore web page. Device labeling, hemo-5303 v9 user manual, addresses the potential for such an occurrence with statements in the general equipment care section such as, "inspect overall physical condition of the system components, peripherals, and interconnecting cables. Perform any corrective actions required. " the troubleshooting section also addresses the potential for such an occurrence with statements in the faq section such as, "question: why isn't the system showing any waveforms or numbers? answer: check for the green light on the pdm and ensure the link is up. Check to see if any cables are disconnected. " and no link from pb1000 [pdm] , - hemo monitor display stops scrolling , - pb1000 led blinks twice every 2 seconds, - pb2000 led blinks twice and then once at 1 second intervals , - pb1000 alarm sounds a continuous low tone. (b)(4). Since there are dual issues reported in this mdr, the following evaluation codes will be for the specific, failed component: client pc: (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 (b)(6) 2017, a customer reported to merge healthcare that the pdm (patient data module) and the client pc mouse/keyboard froze during a procedure. Subsequently, both the hemo monitor and client pc were rebooted three (3) times and resulted in a loss of patient monitoring. It was reported that the patient was moved to another functioning lab onsite. 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 once the patient was moved to another lab. (b)(4).
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Manufacturer (Section D)
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
MDR Report Key6790272
MDR Text Key82943300
Report Number2183926-2017-00167
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 07/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse