MAUDE Adverse Event Report: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PLUS E; SYSTEM, X-RAY, MOBILE, PRODUCT CODE: IZL

Model Number 16580911

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

On november 16th 2023 fujifilm corporation was informed of an event involving fdr go plus e it was reported that the collimator fell off while scanning a patient, no one was hurt.They found two screws missing and a plastic piece that is broken.Mike found one of the screws and put it back on but needs someone to come out to fix and secure the collimator.There is no patient harm or injury reported.There is no additional information provided.

• Brand Name: FDR GO PLUS E
• Type of Device: SYSTEM, X-RAY, MOBILE, PRODUCT CODE: IZL
• Manufacturer (Section D): SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION; 1,nishinokyo-kuwabaracho; nakagyoku, kyoto 64085 11; JA 6408511
• MDR Report Key: 18326176
• MDR Text Key: 330495500
• Report Number: 1000513161-2023-00083
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16580911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1