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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMODYNAMICS COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number MERGE HEMO V.7.20.1
Device Problems Device Operational Issue (2914); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2012
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Merge hemo provides a single server for multiple facilities and departments and allows the user integrate data collection, waveform analysis, inventory control, patient charging and procedure reporting into a single system. This results in a cath lab that is more streamlined, efficient and cost-effective. The touch-screen interface and user-defined workflow eases the transition for physicians and staff. The customer contacted merge on (b)(6) 2012 to report that the tabs have locks on them, but when selecting the lock no hostname is displayed. Merge fixed the error in sql so that case folders where no longer locked by a phantom workstation. Merge explained that this is no longer an issue in later merge hemo releases. The system is designed to allow users to lock a study or tab within the study to make changes. This ensures that two users can not make changes to the same study at the same time. However, in some instances the system will lock tabs within a study even when a second user does not have the study open on a different workstation. This "phantom" lock mimics the behavior described above except the lock is not caused by a second user but by the sql table. The lock might prevent users from calculating certain calculation that are required during the procedure since height and weight might be unavailable. (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5437724
MDR Text Key38219865
Report Number2183926-2015-00371
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
Remedial Action Recall
Type of Report Initial
Report Date 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMO V.7.20.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2012
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2183926-02/15/2016-048-C

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