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U.S. Department of Health and Human Services

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

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KONICA MINOLTA HEALTHCARE AMERICAS, INC. EXA SOFTWARE EXA PACS Back to Search Results
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.
 
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Brand NameEXA
Type of DeviceSOFTWARE EXA PACS
Manufacturer (Section D)
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
2217 us highway 70 east
garner NC 27529 9424
Manufacturer (Section G)
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
2217 us highway 70 east
garner NC 27529 9424
Manufacturer Contact
carolyn russell
2217 us highway 70
garner, NC 27529-9424
9197926420
MDR Report Key11288950
MDR Text Key242896788
Report Number1064396-2021-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUE00N69
Device Catalogue NumberSW-EXA-PACS
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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