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

Model Number PACS V. 6.6.1.1

Device Problems Computer Software Problem (1112); Data Problem (3196)

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

Event Date 11/04/2014

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.New feature was implemented in (b)(4) to handle foreign presentation states.

Event Description

A site using merge pacs reported that a migrated study that has annotations will display that study's annotations, but when a prior is loaded that should have annotations then the second study will not display annotations.Site expressed concerns that seeing no annotations could possibly indicate to the provider that nothing significant was noted when the image was read initially, and therefore could potentially impact the treatment plan or could potentially result in a failure to treat accordingly.

Manufacturer Narrative

Submitting this supplemental report to correct referenced recall report number, and to add fda correction and removal reference numbers.Mdr associated with recall manufacturer number 2183926-01/04/2016-010-c, fda recall numbers z-2303-2016; (b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS
• 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: 5339560
• MDR Text Key: 34921454
• Report Number: 2183926-2015-00028
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACS V. 6.6.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2303-2016; RES 74192
• Patient Sequence Number: 1
• Patient Age: 14 YR