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

Model Number 9.4.4

Device Problem Computer Software Problem (1112)

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

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer of iconnect enterprise archive reported that prefetcher is not retrieving all images from study.The impact on patient is: 1.Additional hour to two plus hours each day manually retrieving previous comparisons by a tech 2.Radiologists do not always have the previous studies since they all need to be manually retrieved in the morning and may not be on their readstation in time, leading to having to do an addendum and at times because they thought a patient would need more imaging when they really didn't (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: 5437824
• MDR Text Key: 38226515
• Report Number: 2183926-2015-00146
• 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
• Type of Report: Initial
• Report Date: 02/15/2015

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: 9.4.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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