MAUDE Adverse Event Report: FUJIFILM CORPORATION SMART CR; COMPUTED RADIOGRAPHY SYSTEM

Model Number CR-IR346RU

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being made out of an abundance of caution.Service engineer visited site and evaluated device to determine cause of event.He replaced power supply, checked device for proper operation after repair and the device was returned to use.Power supply was returned to fujifilm in (b)(4) for analysis by manufacturer.A cr reader unit is used for reading x-ray images that have been exposed on a cr image plate.The smartcr is also known as an xg-1 or a cr-ir 346.There is no indication the system was being used to read image plates at the time of the event.No patients were reported as being involved in the event and no reports of injury were alleged or provided by the reporter.Fujifilm submitted the correction report on march 22, 2016.This addresses a corrective action that will replace the power supply in all smart cr systems.Notification to users was made.

Event Description

A service call was placed for the smart cr unit (s/n (b)(4)) at about 2am cst on (b)(6) 2016.Customer alleges smoke coming from the unit.Hospital staff unplugged the unit and awaited service.Service engineer arrived on-site later that day and determined the power supply to be the issue.A new power supply was ordered (b)(4) and replaced the following day, (b)(6) 2016.The unit was turned over to the hospital in good working order.There was no indication the system was being used to read image plates at the time of the event.No patients were reported as being involved in the event and no reports of injury were alleged or provided by the reporter.

• Brand Name: SMART CR
• Type of Device: COMPUTED RADIOGRAPHY SYSTEM
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: peter altman ; 419 west ave; stamford, CT 06902 ; 2036023576
• MDR Report Key: 5696444
• MDR Text Key: 46468566
• Report Number: 2443168-2016-00005
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CR-IR346RU
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2443168-16/3/22-001-C
• Patient Sequence Number: 1