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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
Device Problems Device Operational Issue (2914); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2011
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. On (b)(6) 2011, the customer reported that there were phantom locks on a patient record. The issue was written up for review by the engineerings hands merge cleared the locks in sql and left voicemail for the site that the case is now available for edit on all tabs. 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 Key5437918
MDR Text Key38228031
Report Number2183926-2015-00374
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
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 Received11/21/2011
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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