MAUDE Adverse Event Report: KONICA MINOLTA HEALTHCARE AMERICAS, INC. EXA; SOFTWARE EXA PACS

Model Number UE00N69

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation concluded the potential root cause is a configuration issue (opal-rad side).Customer sites (site a and site b) requested a destination change during a conference call with a kmha engineering employee for vpn/forwarder services, which potentially contributed to the workflow disruption as concomitant devices.Workflow started with site a (mri modality and worklist) and expected to transfer to site b with multiple opportunities for disruption.Opal has a special transfer syntax "xferobject" utilized when transferring from opal-to-opal system.Opal-rad sending to exa utilizing the transfer syntax 'xferobject' caused zero (0) data files to be generated.The files queued in the receiver on exa causing the service to remain in a continuous transfer loop.Kmha is implementing a future code improvement for exa to ensure if the misconfigure occurs in the future, the transfer is rejected immediately.

Event Description

Customer reported that studies are being received but not moving from cache.Customer reported potential delay in patient care, as the date of the study was (b)(6) 2021 and the study was not received until (b)(6) 2021.

• Brand Name: EXA
• Type of Device: SOFTWARE EXA PACS
• Manufacturer (Section D): KONICA MINOLTA HEALTHCARE AMERICAS, INC.; 2217 us highway 70 east; garner NC 27529 9424
• MDR Report Key: 11288950
• MDR Text Key: 242896788
• Report Number: 1064396-2021-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00817100020193
• UDI-Public: 00817100020193
• Combination Product (y/n): N
• PMA/PMN Number: K142919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UE00N69
• Device Catalogue Number: SW-EXA-PACS
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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