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

Model Number MERGE HEMODYNAMICS 10.0.3

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Various troubleshooting efforts were made between merge healthcare and the customer over the phone and through remote access that included the replacement of ten (10) pieces of hardware to resolve the customer's reported issue.Two (2) other events occurred from the same problem and will be reported to the fda, mdr #2183926-2017-00009 (complaint-(b)(4)) and mdr # 2183926-2017-00010 (complaint (b)(4)).When none of the replacement hardware corrected the issue, merge healthcare went to the site to perform in-person troubleshooting efforts.It was found that the hemo monitor had either a faulty pci serial lava card or (b)(4) conversion card.A replacement hemo monitor was installed.On 06jan2017, merge healthcare observed while the medical staff performed four (4) diagnostic cases in the lab that had the reported problems.All of the procedures were completed successfully without incident.The customer confirmed that no further issues have been encountered since 06jan2017.

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) 2016, a customer reported to merge healthcare that problems were experienced with the hemo monitor freezing in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring.The delay was ~10-15 minutes while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6244638
• MDR Text Key: 64584607
• Report Number: 2183926-2017-00008
• 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: 12/13/2016

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
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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