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

Model Number MERGE PACS 7.0.2

Device Problem Use of Device Problem (1670)

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

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare technical support investigated user logs and determined that this issue was caused by user inaction and user error.Merge pacs was functioning as intended and no issue was found with merge pacs.As of right now, there is no indication that patient was harmed or adverse impact to patient care caused by delay in reading exam.Issue is caused by user error in failure to validate in timely manner and marking study as read.(b)(4).

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 marked for soft copy reading, communication and storage of studies produced by digital modalities.On (b)(6) 2017 a customer reported to merge healthcare that a stat exam had not been read in a timely manner.The customer requested that merge healthcare technical support perform an analysis of the activities for the patient's study.An analysis of the file's logs revealed multiple users accessing the file without validating the study.Additional analysis revealed that after the multiple users had accessed the non-validated study, a user did manually validate the record during a scheduled downtime when the customer's it personnel were performing maintenance on the system.Performing a study validation during system/server downtime prevents the validation command from going through and the file is put into a "failed" status.The logs indicated that the next action was a user marking the study as "final" without validation being performed.Finally on (b)(6) 2017, the logs showed a user manually re-opening the study, reading and validating the report.Merge heatlhcare personnel reviewed the investigation information with the customer.It is the responsibility of the site to review and monitor status queues for any files that have failed to process.This is an activity that is common to pacs devices.While the site is fairly new to merge pacs (october 2016), in person training sessions and merge pacs device labeling provide information instructing users to manage file queues.The customer has confirmed that no serious injury or death resulted due to the delay in validating the stat exam however, there is a potential for injury should this issue reoccur.Merge healthcare worked with the customer to enhance the site's ability to monitor report queues.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr; hartland, WI 53029 ; 2623673570
• MDR Report Key: 6342091
• MDR Text Key: 67926638
• Report Number: 2183926-2017-00039
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 7.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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