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

Model Number MERGE HEMODYNAMICS 9.40

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

Based upon the available information, there is no indication that the reported problem was due to merge healthcare's device malfunctioning.The customer performed simulation testing and found that the problem was due to a cabling issue with an external system.(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 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that problems were experienced with the ekg output to a volcano device.Information obtained from the customer revealed that the problem occurred while a transplant patient was sedated, and the procedure was delayed 20 minutes.It was also reported that the heart catheterization procedure was completed successfully; however, a flow wire study was attempted but cancelled due to the problem.The flow wire study will be completed at the patient's next visit - usually an annual visit unless problems present before then.It was further reported that the problem was not caused by merge hemo but rather a cabling issue with an external system.(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: 5543003
• MDR Text Key: 41719924
• Report Number: 2183926-2016-00522
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• 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