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

Model Number MERGE HEMODYNAMICS 10.0

Device Problems Failure to Power Up (1476); Power Problem (3010); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

The faulty ups has not been received from the customer.When more information becomes available, a supplemental report will be submitted.Hardware not yet returned.

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 the site's hemo client pc appeared to have a hard drive problem.The user pushed the power button and then a loud ticking sound was heard.Upon evaluating, the user found that the ups was defective.If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns.However, the customer confirmed that no patient or staff member was neither injured nor needed treatment as a result of this event.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 14sep2016.The faulty ups (uninterrupted power supply) was never returned to merge healthcare for evaluation and was internally documented on 05oct2017.However, information found in the tripp lite owner's manual for smart and omnismart medical grade ups systems (smart1200xlhg, agsm1200psr3hg) found the following: basic operation "voltage correction" led: this green led lights continuously whenever the ups is automatically correcting high or low ac voltage on the utility line without the assistance of battery power.The ups will also emit a slight clicking noise.These are normal, automatic operations of the ups.No action is required on your part.Based on the above information, results code 213 (no failure detected) was used.It has been deduced that the clicking noise heard by the user was "normal, automatic operations of the ups." revised information contained in this supplemental report includes the following: updated contact office: name/address.Date new information received by manufacturer (hardware evaluation date).Type of report: indication that this is follow-up report 1.Device evaluated by mfr: indication that the device not evaluated by manufacturer; device not returned.(b)(4).Indication of additional manufacturer information and corrected data are contained in this follow-up report.

• 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: 5951756
• MDR Text Key: 54755185
• Report Number: 2183926-2016-00731
• 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,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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