MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number MERGE PACS V6.0 MR4

Device Problem Device Operational Issue (2914)

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

Event Date 02/21/2013

Event Type  malfunction  

Event Description

Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.On (b)(6) 2013 a customer reported that a study status has been changed incorrectly.The logs reported that the study was changed by a staff member; however the staff member did not have system permissions to do so.Merge healthcare identified the root cause to be a design flaw where any user with the change workflow status button can pde any study, even if the user does not have permissions to use the pde tool.There was no report of patient injury.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• 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 drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5544395
• MDR Text Key: 41789080
• Report Number: 2183926-2016-00041
• 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: 02/21/2013

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 V6.0 MR4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2013
• Initial Date FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2010
• 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