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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 10.1.1
Device Problems Nonstandard Device (1420); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2015
Event Type  malfunction  
Manufacturer Narrative
Submitting this supplemental report to add fda correction and removal reference numbers. Note that fda terminated this recall on march 23, 2018.
 
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable.
 
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 (b)(4) that the reporting functionality times out and sends the user back to the study list which causes all reporting data that was entered to be lost. This occurs if the user has the reporting function open for more than an hour, the system will time out and close the reporting function and not save the information entered. This scenario can potentially lead to delay in care.
 
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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 Key5437886
MDR Text Key109235298
Report Number2183926-2015-00131
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051649
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,Followup
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 Number10.1.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0730-2017; RES 75714

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