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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting efforts were made between the customer and merge healthcare over the phone and through remote access.It was determined that there was an issue with the lava serial card.A replacement lava serial card, dual port pcie was sent to the customer on 28jun2017.Further follow up with the customer determined that the lava serial card was installed and no further issues of freezing or buzzing were reported.The faulty unit was scrapped onsite by the customer.Therefore, no further investigation could be performed.

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.The customer reported to merge healthcare that on (b)(6) 2017, the patient data module (pdm pb-1000) was buzzing and froze during testing.The coil cable was replaced and merge hemodynamics was working as expected.Additional follow up with the customer found that on (b)(6) 2017, during a procedure, the hemo monitor froze again and they were not able to get data from the hemo monitor.Subsequently, an external electrocardiogram (ekg) monitor was used in addition to manual charting.The procedure was then completed successfully.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6746091
• MDR Text Key: 81196045
• Report Number: 2183926-2017-00158
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1