MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS

Device Problem Device Issue (2379)

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

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

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.(b)(6) has reported that mammo images from (b)(4) are of poor quality.In (b)(6) it was a determined that (b)(4) needed to supply an update to the firmware and the case was closed.(b)(4) has tried fix the issue and has exhausted all options and that the radiologist is refusing to read mammo studies stating that the image quality is poor.This is isolated to one (b)(4) modality at the customers facility.Much research has been done by development, support and solutions and as of 11/1/15 there is no one root cause.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PACS
• 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: 5437892
• MDR Text Key: 38227673
• Report Number: 2183926-2015-00420
• 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: 02/15/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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