MAUDE Adverse Event Report: AGFA US CORP. DX-D 100; SYSTEM, X-RAY, MOBILE

Model Number 5411/300

Device Problem Data Problem (3196)

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

Event Date 11/02/2020

Event Type  No Answer Provided  

Event Description

Tech went bedside to do portable x-ray.Exposure was taken and image popped up but machine was giving an error message.Error: image not available.No valid pixel file found.Contact your system administrator.Image will not send to picture archive and communication system (pacs) and is irretrievable per agfa.This was an agfa equipment issue not a tech issue.Service repair ticket was entered and agfa service engineer was called to repair issue.Image was not recovered and portable was serviced for repair.Patient was not charged for image and provider did not need additional imaging for patient.Technologist was unable to send processed images to pacs due to error message saying images not available and no valid pixel file found.Vendor resolution notes: closure notes: customer was unable to send processed images to pac due to error message saying images not available no valid pixel file found.Capture the snapshot and case images were uploaded to ftp server for further evaluation.Restart the unit completely and performed flat filed image test and successfully transfer to pacs.Customer to mark unit as down until they really get to the root cause of issue.The equipment was repaired by an agfa engineer.This is all the information we have available.

• Brand Name: DX-D 100
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): AGFA US CORP.; 10 south academy street; greenville SC 29601
• MDR Report Key: 11245025
• MDR Text Key: 229161915
• Report Number: 11245025
• Device Sequence Number: 1
• Product Code: IZL
• 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: 01/15/2021,01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5411/300
• Device Catalogue Number: 55247
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA