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

Model Number MERGE HEMODYNAMICS 10.0.3

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

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The faulty ups unit has not yet been returned by the customer to merge healthcare as of 28dec2016 for evaluation.When more information becomes available, a supplemental report will be submitted.

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 ups (uninterrupted power supply) was beeping.Information obtained from the customer revealed that the failure of the ups unit was found prior to the start of a procedure.The power supply was bypassed to a wall outlet and the procedure was started.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 there were no injury to the patient or staff.With merge hemo not capturing physiological data, there is a potential for delay of treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once an alternate power source was used.(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 29dec2016.The complainant ups (uninterrupted power supply) was returned to merge healthcare on 10jan2017 for evaluation.The evaluation results, available on 12jan2017, showed that the replacement ups unit shipped to the customer was returned unused and was verified by matching the unit's serial number.The unit was re-certified and then sent to service stock.Information found in the tripp lite owner's manual for smart and omnismart medical grade ups systems (smart1200xlhg, agsm1200psr3hg) found the following and may be the reason the customer initially reported a ups failure: basic operation: since the runtime performance of all ups batteries will gradually deplete over time, it is recommended that you periodically perform a self-test (see "mute/test" button description) to determine the energy level of your ups batteries before a blackout or severe brownout occurs.During a prolonged blackout or severe brownout, you should save files and shut down your equipment since battery power will eventually be depleted.When the led turns red and an alarm sounds continuously, it indicates the ups's batteries are nearly out of power and ups shut down is imminent.To run a self-test: with your ups plugged in and turned on, press and hold the mute/test button for two seconds.The alarm will beep several times and the ups will perform a self-test.See "results of a self-test" below.Note: you can leave connected equipment on during a self-test.Your ups, however, will not perform a self-test if it is not turned on (see "power" button description).Caution! do not unplug your ups to test its batteries.This will remove safe electrical grounding and may introduce a damaging surge into your network connections.Results of a self-test: the test will last approximately 10 seconds as the ups switches to battery to test its load capacity and battery charge.** if the "output load level" led remains lit red and the alarm continues to sound after the test, the ups's outlets are overloaded.To clear the overload, unplug some of your equipment and run the self-test repeatedly until the "output load level" led is no longer lit red and the alarm is no longer sounding.Caution! any overload that is not corrected by the user immediately following a self-test may cause the ups to shut down and cease supplying output power in the event of a blackout or severe brownout.If the "battery warning" led remains lit and the alarm continues to sound after the test, the ups batteries need to be recharged or replaced.Allow the ups to recharge continuously for 12 hours, and repeat the self-test.If the led remains lit, contact tripp lite for service.If your ups requires battery replacement, visit www.Tripplite.Com/products/battery-finder/ to locate the specific tripp lite replacement battery for your ups.Revised information contained in this supplemental report includes the following: date device returned to manufacturer.Updated contact office - name/address.Date new information received by manufacturer (hardware evaluation date).Indication that this is follow-up report 1.Indication of additional information and device evaluation.Indication that the device evaluated by manufacturer.(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
• MDR Report Key: 6214991
• MDR Text Key: 63614050
• Report Number: 2183926-2016-00825
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1