MAUDE Adverse Event Report: SHIMADZU COPORATION RADSPEED PROGENERAL RAD DEVICE; GENERAL RAD REVICE

Device Problem Problem with Software Installation (3013)

Patient Problem Radiation Overdose (1510)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

His incident was not a problem with radspeed, but a problem with the x-ray detector (cxdi -401 c compact/701 c wireless) made by canon.Therefore we asked canon to analyze the cause and take measures.This incident happened when the service person updated the control software of the x-ray detectors.The cause is determined as an installation error of the service person, and the work procedure will be notified to the service person once again.This event will not cause any serious health hazards to the patient.Canon reported mdr mfr.Report 1000181430-2019-00002 dated 22 dec 2019 to fda.

Event Description

This occurred on a general rad room, digital patient image were lost due to software corruption.New software was loaded, wasn't realized till after the site tried to take patent images that the networking wasn't working.Windows software updated which corrupted the medical x-ray images causing them to be unrecoverable.

• Brand Name: RADSPEED PROGENERAL RAD DEVICE
• Type of Device: GENERAL RAD REVICE
• Manufacturer (Section D): SHIMADZU COPORATION; 1,nishinokyou kuwabara-cho,nak; kyoto, 60485 11; JA 6048511
• Manufacturer (Section G): SHIMADZU CORPORATIOY; shimadzu corporation 1,nishino; kyoto, 60485 11; JA 6048511
• Manufacturer Contact: toshio kadowaki ; 1,nishinokyou kuwabara-cho,nak; kyoto, kyoto 60485-11 ; JA 6048511
• MDR Report Key: 9518173
• MDR Text Key: 217725010
• Report Number: 8030233-2019-00003
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 74