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

Model Number MERGE HEMODYNAMICS 6.10

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Code Available (3191)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support assisted the customer with preliminary troubleshooting and found that the server would not boot-up into "bios" or diagnostics.The site was then instructed to ship the faulty server to merge healthcare for repair.Upon evaluating the faulty server, a bad memory stick of ram was found and subsequently replaced along with the addition of 1.5 gb memory.The server passed all testing and was returned to the customer.Once re-installed, the server would boot-up and the proper light indicators were lit on the hard drive and led's to the mother board and power supplies; however, there was no video or mouse/keyboard control.Technical support instructed the user to re-seat the cpu (central processing unit).The customer then confirmed that the server was functioning as intended.(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) 2016, a customer reported to merge healthcare that a memory error occurred on the site's server that caused the lab to be "down for a week" and subsequently caused procedures to be rescheduled during that time.With the merge hemo server not functioning as intended, there is a potential for delay in treatment that could result in 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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5976144
• MDR Text Key: 55568540
• Report Number: 2183926-2016-00737
• 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: 08/25/2016

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 6.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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