MAUDE Adverse Event Report: SHIMADZU CORPORATION RADSPEED PRO; STATIONARY BASIC DIAGNOSTIC X-RAY SYTEM, DIGITAL

Model Number	503-79460-41
Health Effect - Clinical Code	Radiation Overdose (1510)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are waiting for the component that seems to be related to this event to be returned.As soon as the components arrive, we will perform an analysis to identify the cause.This event has also been reported by medical institutions to the fda as ref.No.Mw 5094571.
Event or Problem Description
The x-ray condition changed without any operation.The operator took an x-ray without noticing any change in the x-ray condition.

• Brand Name: RADSPEED PRO
• Common Device Name: STATIONARY BASIC DIAGNOSTIC X-RAY SYTEM, DIGITAL
• Manufacturer (Section D): SHIMADZU CORPORATION; 1,nishinokyou kuwahara-cho,; nakagyo-ku; kyoto, kyoto 60485 22; JA 6048522
• MDR Report Key: 10216524
• Report Number: 8030233-2020-00002
• Device Sequence Number: 2485210
• Product Code: KPR
• UDI-Device Identifier: 04540217052479
• UDI-Public: (01)04540217052479(11)170703
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: 503-79460-41
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1