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U.S. Department of Health and Human Services

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

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FUJIFILM CORPORATION SMART CR COMPUTED RADIOGRAPHY SYSTEM Back to Search Results
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.
 
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Brand NameSMART CR
Type of DeviceCOMPUTED 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 Key5418363
MDR Text Key37744338
Report Number2443168-2016-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944046
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCR-IR346RU
Device Catalogue NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/25/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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