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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK ATLAS (SHORT DOOR); CT ATLAS
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SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK ATLAS (SHORT DOOR); CT ATLAS Back to Search Results
Catalog Number 10309477
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
Customer reported smoke coming out of the front of the instrument and smelled a burning odor.Customer safely disconnected power from instrument.No patient samples were being run at time of event.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer had a field service engineer (fse) go on site.Upon review of instrument found damaged ph2 sensor on rackhandler.Appears liquid had dropped on the ph2 sensor and caused a short.Fse replaced ph2 sensor, tested and system is operating within specifications.
 
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Brand Name
CLINITEK ATLAS (SHORT DOOR)
Type of Device
CT ATLAS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SPARTON MEDICAL
22740 lunn road
cleveland OH 44149
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key3961914
MDR Text Key4605950
Report Number1217157-2014-00105
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K932674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10309477
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2014
Initial Date FDA Received07/28/2014
Is the Device Single Use? No
Patient Sequence Number1
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