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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.9.4
Device Problems Application Program Problem (2880); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
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. Customer reported that a case was locked and they could not unlock for data entry. Merge support removed the locks that were on the study manually to allow the site to proceed. The locked tab could potentially impact the system's ability to complete certain calculations as the locked tab could include relevant information. (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 Key5437920
MDR Text Key38218634
Report Number2183926-2015-00365
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.9.4
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 Received04/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2013
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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