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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROLOGICA CORPORATION BODYTOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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NEUROLOGICA CORPORATION BODYTOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number NL4000
Device Problems Misconnection (1399); Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
Upon review by the field service engineer, it was noted that the system was not set up in customer's system to send wireless information.Due to this, the user had to repeat the scan; resulting in the patient receiving additional radiation.The root cause was determined to be a connection error between the scanner and the workstation.Per our calculation the estimated dose received by the patient was 123.04 ctdivol (mgy).
 
Event Description
While the user was completing a scout scan on a patient, an error message was received due to lost connection.As a result of the connection being lost, the user initiated a second scan.Because a second scan was initiated by the user, the patient received additional radiation.
 
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Brand Name
BODYTOM
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
NEUROLOGICA CORPORATION
14 electronics avenue
danvers MA 01923
MDR Report Key12017660
MDR Text Key256766278
Report Number3004938766-2021-00008
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K102677
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNL4000
Was Device Available for Evaluation? No
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2012
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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