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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION BRIGHTSPEED; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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GE HEALTHCARE JAPAN CORPORATION BRIGHTSPEED; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSPE43
Device Problem Image Orientation Incorrect (1305)
Patient Problem Insufficient Information (4580)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
Udi not required.Legal manufacturer: (b)(4).Ge healthcare's investigation into 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 a patient received surgery on the wrong sinus due to an incorrectly oriented scan.
 
Manufacturer Narrative
A patient was scanned with the wrong orientation.The patient was prone but scanned in supine orientation.A ct sinus exam was performed yielding images where the left and right orientation labels were not correct.A surgeon did perform a procedure on the incorrect side.The engineering investigation concluded there was no device malfunction and no usability issue.
 
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Brand Name
BRIGHTSPEED
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
GE HEALTHCARE JAPAN CORPORATION
7-127 asahigaoka 4-chome
hino-shi 191-8 503
JA  191-8503
MDR Report Key10722265
MDR Text Key212701445
Report Number9612283-2020-00001
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K082816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCSPE43
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age22 YR
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