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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE PICTURE ARCHIVING AND COMMUNICATION SYSTEM

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MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE PICTURE ARCHIVING AND COMMUNICATION SYSTEM Back to Search Results
Model Number V9.4.3
Device Problems Computer Software Problem (1112); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2015
Event Type  Malfunction  
Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

 
Event Description

An (b)(6) customer reported that reports are not matching/reconciling after name change. Customer further explained if a trauma patient comes in and patient information is not available immediately, patient is stored under doe patient. When the report is being transcribed as trauma and patient has been discharged, the report type does not match the study after the name change. (b)(4).

 
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Brand NameICONNECT ENTERPRISE ARCHIVE
Type of DevicePICTURE ARCHIVING AND COMMUNICATION SYSTEM
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 rd
hartland, WI 53029
2629123570
MDR Report Key5437610
MDR Text Key38970458
Report Number2183926-2015-00202
Device Sequence Number1
Product Code LMB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation HEALTH PROFESSIONAL
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 HEALTH PROFESSIONAL
Device MODEL NumberV9.4.3
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 Received11/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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