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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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MERGE HEALTHCARE MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number MERGE CARDIO 10.1
Device Problems Loss of Data (2903); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2015
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. Merge received complaint of reporting timing out and sending user back to study list which causes all reporting data being entered to be lost. This occurs if the user has the reporting open for more than an hour, the system will close the reporting and will not save the information entered. The system is designed to timeout and close the reporting after an hour of inactivity. After one hour, the service will clean up all resources of the inactive session. This results in the report not saving any of the information entered. This workflow is most common with pediatric cases and ep studies. In pediatric cases, the physicians require more than an hour for reporting due to the level of detail and research required for such reports. Ep studies typically last more than 3 hours and reporting is open for the duration of the studies. (b)(4).
 
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Brand NameMERGE CARDIO
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge dr.
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge dr.
hartland WI 53029
Manufacturer Contact
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5437600
MDR Text Key38218529
Report Number2183926-2015-00157
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051569
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 CARDIO 10.1
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 Received10/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2183926-02/15/2016-035-C

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