MAUDE Adverse Event Report: FUJI MEDICAL SYSTEM COMPUTED RADIOGRAPHY READER; PROCESSOR, RADIOGRAPHIC FILM, AUTOMATIC

Model Number FCR XG5000

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

Xray monitor stopped working; would not turn on.

• Brand Name: COMPUTED RADIOGRAPHY READER
• Type of Device: PROCESSOR, RADIOGRAPHIC FILM, AUTOMATIC
• Manufacturer (Section D): FUJI MEDICAL SYSTEM; 419 west avenue; stamford CT 06902
• MDR Report Key: 4877582
• MDR Text Key: 5866306
• Report Number: 4877582
• Device Sequence Number: 1
• Product Code: IXW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/24/2015

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: FCR XG5000
• Device Catalogue Number: CR-IR-362
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 73 YR