MAUDE Adverse Event Report: SHIMADZU CORPORATION SHIMADZU; RADSPEED PRO

Model Number	503-79460-41
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	Radiation Overdose (1510)
Date of Event	04/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of confirmation by the manufacture, it was found that the cause was an error in the installation.Based on risk analysis, we consider the risk of such incidents to be at a minimal level.
Event or Problem Description
Technician said she took a radiological image on the upright wall stand and received no image after producing x-ray.Corrective action did not recover a patient image.

• Brand Name: SHIMADZU
• Common Device Name: RADSPEED PRO
• Manufacturer (Section D): SHIMADZU CORPORATION; 1, nishinokyo-kuwabaracho; nakagyo-ku; kyoto city, 604-8 511; JA 604-8511
• MDR Report Key: 8924010
• Report Number: 8030233-2019-00001
• Device Sequence Number: 11269834
• Product Code: KPR
• UDI-Device Identifier: 04540217052479
• UDI-Public: (01)04540217052479(11)170124
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/07/2019
• Report Date (Section F): 06/08/2019

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: Other
• Device Expiration Date: 01/24/2017
• Device Model Number: 503-79460-41
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR