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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE EFILM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 3.4
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2015
Event Type  malfunction  
Manufacturer Narrative
Upon review of this customer issue, it was determined to be reportable as an mdr.
 
Event Description
Efilm workstation is a software application that is used for viewing medical images. Efilm workstation receives digital images and data from various sources (including but not limited to ct, mr, us, rf units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). A customer reported (case (b)(4) they were unable to send studies to the pacs server. This was determined to be a potential safety issue in the event the information is not available for review.
 
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Brand NameMERGE EFILM
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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 Key5437811
MDR Text Key38228022
Report Number2183926-2016-00030
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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 Number3.4
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 Received11/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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