MAUDE Adverse Event Report: SHIMADZU COPORATION FDR GOFDR GO; MOBILE X-RAY SYSTEM

Model Number	503-79888-11
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We, as a manufacturer, believe that the cause is the carelessness of the user.Collecting logs and checking for equipment malfunctions.
Event or Problem Description
When the user was reversing the fdr go after the user was finished taking an x-ray of patient in the bed and was backing the go away from the bed, the fdr go made a sudden movement turn and back left wheel ran over the user's right foot.Service engineer was onsite, he says user was using only one hand to drive the fdr go, so that's why the fdr go turned one way.User suffered moderate bruising of her foot, however there were no broken bones.
Event or Problem Description
When the user was reversing the fdr go after the user was finished taking an x-ray of patient in the bed and was backing the go away from the bed, the fdr go made a sudden movement turn and back left wheel ran over the user's right foot.Service engineer was onsite, he says user was using only one hand to drive the fdr go, so that's why the fdr go turned one way.User suffered moderate bruising of her foot, however there were no broken bones.
Additional Manufacturer Narrative
Since the operation was carried out with one hand as reported from the site, the fdr go reacted sensitively, causing a rapid rotational movement, and we determined that this event occurred.The medical institutions also recognize that one of the causes of the occurrence of this event was the operation with only one hand.In the instruction manual, we instruct not to operate with one hand.Therefore, we concluded that a corrective action is unnecessary.Attachment: [sqbg-0006.Pdf].

• Brand Name: FDR GOFDR GO
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SHIMADZU COPORATION; 1, nishinokyou kuwabara-cho,; nakagyo-ku; kyoto, kyoto 60485 11; JA 6048511
• MDR Report Key: 9947492
• Report Number: 8030233-2020-00001
• Device Sequence Number: 19536823
• Product Code: IZL
• UDI-Device Identifier: 04540217053438
• UDI-Public: (01)04540217053438(11)161220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 503-79888-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1