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

Model Number 503-79888-11

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

We, as a manufacturer, believe that the cause is the carelessness of the user.Collecting logs and checking for equipment malfunctions.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 198178002
• Report Number: 8030233-2020-00001
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 04540217053438
• UDI-Public: (01)04540217053438(11)161220
• Combination Product (y/n): N
• PMA/PMN Number: K080701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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