MAUDE Adverse Event Report: FUJIFILM CORPORATION FDR GO FLEX DR-ID700; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number FUJI FDR GO

Device Problem Charging Problem (2892)

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

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Tech was unable to shoot xray w/machine.It appeared it hadn't been charged.After plugging machine in and waiting, images were obtained.Reporting out of an abdundance of caution.

• Brand Name: FDR GO FLEX DR-ID700
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): FUJIFILM CORPORATION; 81 hartwell ave; suite 300; lexington MA 02421
• MDR Report Key: 11482182
• MDR Text Key: 239707680
• Report Number: 11482182
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

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: Other
• Device Model Number: FUJI FDR GO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1