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

Model Number 3.4

Device Problem Data Problem (3196)

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

Event Date 11/13/2015

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 ((b)(4)) that they were unable to send images to the server. The investigation showed this was an issue with the permissions the user set when they built the database. This was determined to be a potential safety issue in the event the information is not available for review.

• Brand Name: MERGE EFILM
• Type of Device: SYSTEM, 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 Key: 5437805
• MDR Text Key: 38217912
• Report Number: 2183926-2016-00026
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012211
• Number of Events Reported: 1
• 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 Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3.4
• 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 Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse