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

Model Number MERGE HEMODYNAMICS 10.0

Device Problem Application Program Problem (2880)

Patient Problem No Information (3190)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

The reported problem is currently under investigation (b)(4).A follow-up report will be submitted when the investigation is complete.

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 both hemo monitor displays "went blank" during an active case.The monitors were replaced immediately by onsite personnel.The level of patient impact is unknown at this time even though several attempts have been made to reach the customer.Replacement hardware was shipped to the customer on (b)(6) 2016.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.(b)(4).

Manufacturer Narrative

Merge healthcare conducted an internal quality investigation to address the issue reported in recall 2183926-02/15/2016-031-c, fda recall number z-0665-2017.Merge healthcare received reports of the hemo monitor application unexpectedly stopping to display and update patient data.When this issue occurs, the hemodynamics system is no longer capturing patient data.For customers who experience this issue, it is recommended that the hemo monitor pc is power cycled.Once the system is powered up, the hemo application should restart with normal functionality and will once again display, update and record patient data.The restarting of the hemo monitor pc may result 0630in a delay of up to two minutes while the system reboots.The investigation and troubleshooting activities conducted by merge healthcare found that the issue occurred due to an error when interfacing with a specific location within a schiller pdm (patient data module) file.Merge has validated and released a firmware fix for this issue.This fix is incorporated into the software upgrade of merge hemo 9.40.3 patch 1 (or later), or merge hemo 10.0.3 patch 1 (or later).The correction has been verified to be effective as is evidenced through the large reduction of customer complaints concerning this issue.Revised information contained in this supplemental report includes the following: g7 - indication that this is follow-up report 1.H6 - evaluation codes: methods: 22 software evaluation.Results: 110 design error [the device or component had faulty (incomplete or incorrect) software design].Conclusions code: 12 design deficiency [the device problem was traced back to the design specifications (e.G.In the requirements, testing processes, hazard analysis, implementation strategy].H10 - indication of additional manufacturer information is 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: 5576975
• MDR Text Key: 42758500
• Report Number: 2183926-2016-00552
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

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 10.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 05/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0665-2017
• Patient Sequence Number: 1