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Model Number MERGE HEMODYNAMICS 9.40.1
Device Problems Failure to Transmit Record (1521); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the customer's hemo case management within merge healthcare's internal database found that the reported freezing issue has been an ongoing problem at the site. All hardware and cabling have recently been replaced with the exception of the hemo monitor. Merge healthcare concluded that this hardware should also be replaced so a new unit (b)(4) was shipped to the customer on (b)(6) 2017 that contained a new brand of cyber serial card (b)(4). The faulty unit was returned to merge healthcare on aug 22, 2017. The results showed that unit had a (b)(4) serial card installed. (b)(4) serial cards have been found to cause connection issues in the past, so it was replaced with a (b)(4) brand serial card. The drives on the faulty unit were wiped, the unit was reloaded with software, the unit passed all diagnostic testing, and it ran for five (5) days without issue. The unit was then sent to service stock. An internal investigation ((b)(4)) found that the (b)(4) 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 In order to proactively eliminate this issue, any hemo monitor that is returned with an outdated serial card will be replaced with (b)(4) brand cards. It was also found that the customer was on an outdated version of merge hemodynamics so technical support upgraded the site to hemo v9. 40. 3 patch 1 as well as updated the firmware on the site's pdm's (patient data modules). (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 hemo monitor froze during a procedure. The medical staff rebooted the hemo system that resulted in a loss of patient monitoring. Information obtained from the customer revealed that the procedure was paused/stopped while the medical staff waited for the hemo system to reboot and it was noted that the non-emergent patient had already been sedated. The customer further stated that, in their opinion, there was no injury or adverse effect to the patient during this time. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could result in harm to the patient. The procedure was completed successfully once the hemo system was rebooted. (b)(4).
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Manufacturer (Section D)
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Manufacturer (Section G)
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Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
MDR Report Key6867785
MDR Text Key86413955
Report Number2183926-2017-00179
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,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse