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

Model Number FUSION PACS V2.2

Device Problem Device Operational Issue (2914)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information is still being gathered and a follow-up report will be submitted.

Event Description

Fusion pacs is intended for the transmission, archiving and review of radiological images.On (b)(6) 2017, a customer called merge technical support alleging that a hard drive on their fusion pacs server failed and the fusion pacs software needed to be reinstalled.The customer's images and fusion pacs database were stored on a different hard drive therefore, there was no loss of patient data.However, the customer was unable to use their fusion pacs for seven days while merge support worked to install the software.Due to the loss of access, there is a potential that a delay could lead to harm however, there is no indication that any patients were harmed due to this issue.(b)(4).

Manufacturer Narrative

Following an investigation, the following information has been found: customer's fusion pacs went down due to a hard drive failing on their fusion pacs server.That hard drive contained the (b)(6) operating system and the fusion pacs software needed to store and review studies stored on the file systems.The drive did not contain the fusion pacs database, image data, or patient data.The customer obtained a replacement hard drive, installed a fresh (b)(6) operating system, and located a backup of the fusion pacs database.These tasks took approximately two days to complete.Support then installed the fusion pacs software, configured it, and restored a backup of the fusion pacs database.The install, configuration, and database restore took approximately five days to complete.Revised information contained in this supplement report includes the following: added additional clarification to information previously received.Indication that this is a follow-up report.Device not manufactured by reporting firm (merge healthcare did not manufacture the hard drive that failed on the server).No failure detected, device operated within specifications (the merge fusion pacs operated as expected per specifications, the failure occurred on/due to a hard drive (hardware) issue)).

Event Description

Further investigation was performed and it was found that customer's fusion pacs was down for approximately seven days.During that downtime, the facility had to close down for two days and six procedures had to be rescheduled.Radiologists did read some exams from the modality as a workaround during the downtime.No patients were harmed due to the downtime.

• Brand Name: FUSION 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: 6490516
• MDR Text Key: 72798674
• Report Number: 2183926-2017-00084
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION PACS V2.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• 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