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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROLOGICA CORPORATION CERETOM ELITE; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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NEUROLOGICA CORPORATION CERETOM ELITE; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number NL3000
Device Problem Unintended System Motion (1430)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
Upon review by the field service engineer, it was noted that there was nothing on the floor or on the device that may have caused the wheels to stutter.The root cause was determined to be an internal cable failure that caused the scanner to fail while attempting to complete a scan.The cable was replaced by field service and the device was confirmed to be functioning normally.Because the user had to repeat the patient scans, it was determined that the dlp delivered to the patient was 1.62gy.Cm.
 
Event Description
While the user was completing a scan on a patient, the scanner started stuttering.As a result of this, the device failed to travel the appropriate distance to produce the necessary images and the customer scanned the patient two additional times.Because two additional scans were initiated by the user, the patient received more radiation than anticipated.
 
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Brand Name
CERETOM ELITE
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
NEUROLOGICA CORPORATION
14 electronics avenue
danvers MA 01923
MDR Report Key12379856
MDR Text Key272900868
Report Number3004938766-2021-00011
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K172539
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Repair
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNL3000
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
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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