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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSPI45
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Ge healthcareâs investigation is ongoing.A follow up report will be submitted after the investigation has been completed.Udi not required.Legal manufacturer: (b)(6).
 
Event Description
It was reported that a patient penetrated the scan window during a ct scan; sustaining a scratch.While there was no serious injury, penetration of the scan window during scanning could result in a serious injury.Serious injury is not likely since the scan window itself is designed to distance the patient from rotating parts while affording diagnostic image quality.Serious injury is not the normally anticipated outcome associated with patient motion issues.
 
Manufacturer Narrative
The root cause was determined to be unintended user error, i.E.The operator did not properly position and strap the patient securely for the procedure.The user manual provides instructions on appropriate patient positioning.
 
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Brand Name
OPTIMA 660
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
MDR Report Key12232958
MDR Text Key264323504
Report Number9613445-2021-00003
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K131576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCSPI45
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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