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

Model Number 9

Device Problems Device Stops Intermittently (1599); Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997)

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

Event Date 03/21/2014

Event Type  malfunction  

Event Description

The merge hemo system is comprised of two off the shelf pcs and a pt data module to provide vitals monitoring.One of the pcs is used to record data is a pt's electronic medical record.The second pc is used to display the data an waveforms received from the pt data module.This pc is referred to as the hemo monitor pc.It was brought to the attention of merge healthcare that the hemo monitor experienced a random crash during a cardiac cath case.The error was initially reported as an isolated incident in (b)(6) 2013.The error was unreproducible by merge healthcare and was not reported from the field as occurring again.On (b)(6) 2014, the error was reported again.The hemo monitor pc intermittently crashed and displayed an error reading "hemomonitor.Exe has stopped working unexpectedly." the issue has since been reported multiple times from several customer sites.Engineering has been working diligently researching the error and trying to reproduce since (b)(6).Two sites have returned pcs to merge for eval.At this time, merge is unable to reproduce or find a root cause.After crash, the hemo monitor is able to be brought right back up, minimizing the time a site is without real time waveforms.The merge hemo system also has the ability to interface with third party monitors to ensure the pt's vital signs may still be monitored and recorded during the outage.At this time, the issue is suspected to be caused by the operating system upgraded from windows xp to windows 7 64-bit.Prior to this upgrade, there were no reports of the hemo monitor crashing this way.Once a root cause is found, merge will correct the issue in the next planned revision of software.At this time, merge will provide a customer notification to sites with version 9 windows 7 hemo monitor pc detailing the issue, how to restart and how to contact support if more info is required.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE, INC; 900 walnut ridge dr; hartland WI 53089
• Manufacturer Contact: hilarie tuerk ; 900 walnut ridge dr; hartland, WI 53029 ; 2629123497
• MDR Report Key: 4647769
• MDR Text Key: 5618659
• Report Number: 2183926-2014-00001
• 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: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/18/2014

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: 9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1