MAUDE Adverse Event Report: EXA; SOFTWARE EXA PACS

Model Number	UE00N69
Medical Device Problem Codes	Failure to Transmit Record (1521); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SOFTWARE EXA PACS
• MDR Report Key: 11288950
• Report Number: 1064396-2021-00001
• Device Sequence Number: 4126119
• Product Code: LLZ
• UDI-Device Identifier: 00817100020193
• UDI-Public: 00817100020193
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: UE00N69
• Device Catalogue Number: SW-EXA-PACS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1