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

Model Number V 9.1.2

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported end users are experiencing issues retrieving prior studies to the local facility image cache (fic).There are multiple workflows that can lead to the problem: 1.Studies for patients retrieved to the local fic will have a local mrn of the rightmost prefixed value in the other patient id (opid) field of the lta.When the rightmost value is not the most recent, the study will retrieve back to the fic under the "wrong" local mrn.2.If the corresponding patient record on the lta does not have a prefixed value in the opid field for that fic, then the study will be sent from the lta to the fic with an mrn of no_fid-cmrn.The study will store successfully to the fic under that mrn, but the end user may not realize it stored as such unless they search by patient name.A.The 1/2 folder will still exist in radsuite on that local fic with the correct local mrn for the patient.B.The end user will not have any errors reported for the retrieve attempt as it was considered successful.This issue could potentially result in studies getting read without priors or a delay in patient care while pacs admins try to investigate the issue with priors when reported.(b)(4).

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: IMAGE 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 Key: 5437820
• MDR Text Key: 38218925
• Report Number: 2183926-2015-00137
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE. EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V 9.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1