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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE IMAGE ARCHIVE

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MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE IMAGE ARCHIVE Back to Search Results
Model Number 9.1.2
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Customer reported that priors are failing to retrieve back to facility image cache (fic) for one patient. The pacs admin retrieved the priors manually. User used qc function to make a change in the data and inadvertently connected the studies to another patient. Further analysis has found that at some point, the customer modified a group of studies on the long term archive (lta) at the site which resulted in the studies being placed under an incorrect patient. (b)(4).

 
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Brand NameICONNECT ENTERPRISE ARCHIVE
Type of DeviceIMAGE ARCHIVE
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 Key5437880
MDR Text Key38219246
Report Number2183926-2015-00138
Device Sequence Number1
Product Code LMB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNONE. EXEMPT
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 Number9.1.2
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 Received07/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2014
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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