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 01/05/2016

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 verbal report of the event was provided by the site to fujifilm medical systems, u.S.A., inc.(fmsu) on (b)(6) 2016.On 2/1/2016 fmsu received a copy of a medsun report from the fda that had been submitted by the site.The site did not provide this medsun report directly to fmsu.The uf report # has been included in the appropriate field of this report.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.This mdr will be supplemented with additional information as necessary once the investigation is complete.

Event Description

Customer reported that a smartcr computed radiography (cr) reader unit in the emergency department was emitting smoke from the underside.The unit was removed from its location and taken out of service until a fuji service representative could arrive.The unit was powered on at the time of the event, although 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.

• 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: arye hess ; 419 west ave; stamford, CT 06902 ; 2036023652
• MDR Report Key: 5418363
• MDR Text Key: 37744338
• Report Number: 2443168-2016-00001
• 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: Radiologic Technologist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/25/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1