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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE, INC MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameMERGE HEMO
Type of DeviceCOMPUTER, 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 Key4647769
MDR Text Key5618659
Report Number2183926-2014-00001
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082421
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/21/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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