MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)

Model Number MERGE PACS V6.4.1

Device Problems Computer Software Problem (1112); Device Issue (2379)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare continues to support and work with the customer to attempt to get all tapes on the server available for read/write functionality.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016, merge healthcare was notified by a customer that an automated daily report indicated that three of their archived tapes were showing as unavailable.Should a tape with archived patient data be requested for viewing, there is a potential that the information may not be available due to the pacs system not being able to retrieve/read the requested information.This could potentially lead to a delay in treatment or diagnosis due to unavailable data.Currently, there is no known or alleged impact to specific or overall patients.Merge healthcare's initial investigation results indicate that the customer is running on server software/firmware that is antiquated and is no longer supported by the oem.(b)(4).

Manufacturer Narrative

After further investigation by the merge healthcare development team, it was determined that this issue was due to corrupted 3rd party storage tapes.Development successfully removed studies from corrupted tapes and re-archived to new tapes.These studies are being stored for historical purposes and have already been reviewed for treatment and diagnosis.Historic patient reports are available to physicians for comparison purposes.The primary/current image is the basis for treatment and diagnosis as it contains the most recent images.Any prior images that were evaluated in the past are used as aids only for comparison or historical purposes.Based on the results of merge healthcare's investigation, the customer's complaint does not meet the requirements for medical device reporting.The customer's issue did not result in harm nor would a recurrence have a remote or greater likelihood to result in a death or a serious injury.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: results code: 213 no failure detected.Conclusions code: 17 evaluation conclusion.71 no failure detected, device operated within specification.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• MDR Report Key: 5525231
• MDR Text Key: 41121685
• Report Number: 2183926-2016-00506
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS V6.4.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1