Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROLOGICA CORPORATION OMNITOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEUROLOGICA CORPORATION OMNITOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number NL5000
Device Problem Use of Device Problem (1670)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
It was determined that this incident was user induced, as the user was not driving the device safely.The user was attempting to maneuver the device through a doorway, while holding the door open with their foot.Not considering the space needed for the device to fit through the door, the users ankle got caught, resulting in injury.To help mitigate this issue, the site has been advised to not put the operator between an immovable object and the system during transport.The device should also be driven with two hands on the drive bar.The site was also offered additional clinical training for appropriate techniques to follow while driving the device.
 
Event Description
It was reported that the technologist was attempting to maneuver the device through a doorway, when her leg became trapped between the device and the door.The collision caused her to fall to the ground.Upon evaluation, it was determined that the technician had fractured her ankle.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OMNITOM
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
NEUROLOGICA CORPORATION
14 electronics avenue
danvers MA 01923
MDR Report Key12305359
MDR Text Key265987498
Report Number3004938766-2021-00010
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K171183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Inspection
Type of Report Initial
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
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
Date Manufacturer Received07/13/2021
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
-
-