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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO HEMODYNAMICS MONITORING AND RECORDING SYSTEM

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MERGE HEALTHCARE MERGE HEMO HEMODYNAMICS MONITORING AND RECORDING SYSTEM Back to Search Results
Model Number 9.30
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2014
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to require an mdr.
 
Event Description
Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Customer reported that top row icons on the hemomonitor were grayed out which prevented the user from recording vitals. After further investigation it was determine that the hemomonitor pc was not communicating with client pc. The solution was to reboot the hemomonitor which interrupts vital monitoring. This case did not specify if there was a patient present at the time of the event; however, if the issue reoccurs, the lack of vital monitoring is not acceptable if the patient was in the room. (b)(4).
 
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Brand NameMERGE HEMO
Type of DeviceHEMODYNAMICS MONITORING AND RECORDING SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53209
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53209
Manufacturer Contact
michael diedrick
900 walnut ridge drive
hartland, WI 53209
2629123570
MDR Report Key5437618
MDR Text Key38227616
Report Number2183926-2015-00310
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 Number9.30
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 Received12/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2013
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2183926-02/15/2016-041-C

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