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

Model Number MERGE HEMO V10.0.1

Device Problem Device Operational Issue (2914)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2016

Event Type  malfunction  

Event Description

Merge hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.During a cardiac catheterization procedure, all three monitor screens went black and the patient data module (pdm) emitted a beeping tone.The site rebooted the hemo pc multiple times in order to load the windows 7 operating system.Once the user was able to log into windows, merge healthcare's support technician remotely connected to the hemo pc and created a shortcut in the startup for the hemo monitor application in order to get the merge hemo application functioning again.Once that was complete, the procedure resumed and was completed.There was a patient on the table and the procedure was delayed by 35 minutes.With merge hemo not presenting physiologic data during a cardiac catherization procedure, there is a potential for a delay in care that results in harm to the patient.The customer did confirm that the procedure completed successfully and there was no harm to the patient.Following this event, the customer requested that the operating system and merge hemo application be reinstalled on the pc.A technician was sent on site on 1/22/2016 to reinstall the operating system and merge hemo application.

Manufacturer Narrative

The patient that was on the table when this event occurred was not harmed, however, additional sedation had to be administered due to the delay.The patient's demographs is unknown.

Event Description

Merge hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.During a cardiac catheterization procedure, all three monitor screens went black and the patient data module (pdm) emitted a beeping tone.The site rebooted the hemo pc multiple times in order to load the (b)(4) operating system.Once the user was able to log into windows, merge healthcare's support technician remotely connected to the hemo pc and created a shortcut in the startup for the hemo monitor application in order to get the merge hemo application functioning again.Once that was complete, the procedure resumed and was completed.There was a patient on the table and the procedure was delayed by 35 minutes.With merge hemo not presenting physiologic data during a cardiac catheterization procedure, there is a potential for a delay in care that results in harm to the patient.The customer did confirm that the procedure completed successfully and there was no harm to the patient.Following this event, the customer requested that the operating system and merge hemo application be reinstalled on the pc.A technician was sent on site on (b)(4) 2016 to reinstall the operating system and merge hemo application.(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 0630 in 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: updated contact office: name/address.Date new information received by manufacturer (planned implementation date).Indication that this is follow-up report 1.Indication of malfunction as reportable event.Indication of additional information and device evaluation.Indication that device evaluated by manufacturer.Software evaluation.Design error [the device or component had faulty (incomplete or incorrect) software design].Design deficiency [the device problem was traced back to the design specifications (e.G.In the requirements, testing processes, hazard analysis, implementation strategy].Addition of fda assigned recall reporting number.Indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5450584
• MDR Text Key: 38652396
• Report Number: 2183926-2016-00445
• 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,Followup
• Report Date: 01/21/2016

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 HEMO V10.0.1
• Device Catalogue Number: 10.0.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017
• Supplement Dates FDA Received: 04/26/2016; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0665-2017
• Patient Sequence Number: 1