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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problem Electronic Property Issue (2928)

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect hardware component is a ups, tripp lite 1000va, and a replacement was shipped from merge healthcare's (b)(4) site to the customer on 3/31/2016.The actual hardware was returned by the customer.Upon completion of the evaluation, the batteries appeared to have overcharged and expanded to the point of failure.

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 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 hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the uninterrupted power source (ups) batteries had ruptured.A report of ruptured batteries and/or a malfunctioning ups can lead to a potentially hazardous situation for users and/or patients.The customer confirmed that there was no patient involvement and no user harm was reported.(b)(4).

Manufacturer Narrative

The initial report submitted to the fda on 01may2016 stated in the narrative, "on (b)(6) 2016, a customer reported to merge healthcare that the uninterrupted power source (ups) batteries had ruptured." however during documentation review activities conducted by merge healthcare, it was found that the battery had not ruptured but instead had swollen.In addition, there was no conclusion code added in the initial report.Information concerning the swelled state of batteries was not found in the tripp lite owner's manual; however, the owner's manual states that the ups unit should be charged for 12 hours and a unit self-test should be completed prior to use to ensure the battery operates correctly.Additional information was obtained from an online source ((b)(6)) and provided the following information concerning swollen sla batteries: sealed lead acid batteries (also known as a vrla, valve regulated lead acid battery) both agm and gelled electrolyte can swell up and expand sometimes.This happens due to the construction of lead acid batteries which is referred to as "recombinant".They are constructed in such a way to allow absorption of gasses released during the chemical process inside the battery.The cell plates most often expand due to overcharging of the battery.The battery may also expand due to shorting of the terminals of the battery.Both of these situations result in heating up of the cell plates inside the battery.The lead of the cell plates has a high expansion rate when heated.The outcome is that the battery experiences extreme pressure inside that swells up and deforms it.The swelling-up of the battery may also cause great damage to the internal components and parts.Since there were no reports of patient involvement and no reports of harm to the medical staff, the risk level has been assessed as low (non-serious injury).No further actions are anticipated at this time as the issue is readily apparent to the user and the ability to correct the issue through bypassing the ups and connecting the hemo system to a hospital grade outlet.Revised information contained in this supplemental report includes the following: updated contact office - name/address, date new information received by manufacturer (supplemental creation date), indication that this is follow-up report 1, indication of malfunction as reportable event, indication of correction and additional information, device manufacture date, evaluation codes: note: patient, device, method, and results codes were included in the initial report so this supplemental report only provides the conclusions code.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: 5622874
• MDR Text Key: 44130501
• Report Number: 2183926-2016-00567
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1