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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 Unintended System Motion (1430); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The field service engineer replaced the drive bar and components.Calibration and qa was completed.Field service engineer test drove the scanner, and successfully completed daily calibration.No patient harm or other issues reported.
 
Event Description
Caller reported the scanner pinned operator when trying to maneuver the device and broke the drive bar.No reported injury to the operator.
 
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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 ave
danvers, MA 01923
9785648632
MDR Report Key11043001
MDR Text Key228053307
Report Number3004938766-2020-00014
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNL5000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2020
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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