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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROLOGICA CORPORATION OMNITOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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NEUROLOGICA CORPORATION OMNITOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number NL5000
Device Problems Inadequate or Insufficient Training (1643); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
It was reported by the customer that the scanner was not driving correctly.When pressing the drivebar to move the device, the device was said to move backwards.Per feedback received from field service, a technician was pinned against the wall while attempting to drive the device.No injury to the operator was reported.
 
Manufacturer Narrative
It was reported by a customer that a scanner was driving incorrectly.While driving the device, a technician was pinned against a wall.There was no additional information on user injury provided.While further investigating, the field service engineer determined that the wheel hubs were malfunctioning, which contributed to the difficulty in driving the device the user experienced.However, it was also conveyed that the technician who drove the scanner was not adequately trained on driving the device.The drive bar and required components were replaced and the field service technician stated the device was working appropriately after the repair.To further mitigate this incident, neurologica will be conducting a training seminar with the site on how to appropriately drive the device.
 
Event Description
It was reported by the customer that the scanner was not driving correctly.When pressing the drivebar to move the device, the device was said to move backwards.Per feedback received from field service, a technician was pinned against the wall while attempting to drive the device.No injury to the operator was reported.
 
Manufacturer Narrative
It was reported by a customer that a scanner was driving incorrectly.While driving the device, a technician was pinned against a wall.There was no additional information on user injury provided.While further investigating, the field service engineer determined that the wheel hubs were malfunctioning, which contributed to the difficulty in driving the device the user experienced.However, it was also conveyed that the technician who drove the scanner was not adequately trained on driving the device.The drive bar and required components were replaced and the field service technician stated the device was working appropriately after the repair.To further mitigate this incident, neurologica will be conducting a training seminar with the site on how to appropriately drive the device.
 
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Brand Name
OMNITOM
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
NEUROLOGICA CORPORATION
14 electronics avenue
danvers MA 01923
Manufacturer (Section G)
NEUROLOGICA CORPORATION
14 electronics avenue
danvers MA 01923
Manufacturer Contact
ninad gujar
14 electronics avenue
danvers, MA 01923
9785648632
MDR Report Key12847856
MDR Text Key286236353
Report Number3004938766-2021-00015
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNL5000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2019
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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