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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIR TECHNIQUES INC. SCANX IO
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AIR TECHNIQUES INC. SCANX IO Back to Search Results
Model Number B7100C
Device Problems Fire (1245); Arcing (2583); Lack of Maintenance Documentation or Guidelines (2971)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2018
Event Type  malfunction  
Event Description
Customer reported flames coming from the external power.Customer was preparing to process images when the incident occurred.Transport was not yet activated and the unit was idle when she stated she saw flames coming from the external power supply.Per the customer there was no electrical storm or construction in the nearby vicinity.There were no reports of injury.No emergency services were contacted.
 
Manufacturer Narrative
A device was sent for further evaluation to determine the root cause.
 
Event Description
Customer reported flames coming from the external power.Customer was preparing to process images when the incident occurred.Transport was not yet activated and the unit was idle when she stated she saw flames coming from the external power supply.Per the customer there was no electrical storm or construction in the nearby vicinity.There were no reports of injury.No emergency services were contacted.
 
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Brand Name
SCANX IO
Type of Device
SCANX IO
Manufacturer (Section D)
AIR TECHNIQUES INC.
1295 walt whitman road
melville,
Manufacturer (Section G)
AIR TECHNIQUES INC.
1295 walt whitman road
melville NY 11747
Manufacturer Contact
joseph latkowski
1295 walt whiman road
meville, NY 11747
5162145574
MDR Report Key7776792
MDR Text Key117153788
Report Number2428225-2018-00004
Device Sequence Number1
Product Code MUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberB7100C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2011
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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