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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION BRIGHTSPEED 16; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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GE HEALTHCARE JAPAN CORPORATION BRIGHTSPEED 16; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSPE16
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's investigation in the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that the imaging system may have caused/ contributed to a thermal event at this customer facility.The system was not in use; but was powered on.The fire alarm sensor gave the alert to local security.There were no reports of injury.
 
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Brand Name
BRIGHTSPEED 16
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
GE HEALTHCARE JAPAN CORPORATION
7-127 asahigaoka 4-chome
hino-shi
JA 
Manufacturer Contact
jason kelly
3000 n grandview blvd
waukesha, WI 
MDR Report Key6722862
MDR Text Key80405863
Report Number9612283-2017-00001
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K082816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCSPE16
Device Lot Number211319HM9
Other Device ID NumberNOT REQUIRED
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/19/2017
Date Device Manufactured01/13/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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