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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS - LONG DOOR
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS - LONG DOOR Back to Search Results
Catalog Number 10317674
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
Siemens service went onsite and found the issue to be a burnt capacitor on the power driver board.A new board has been ordered and service has scheduled a return visit to install it.
 
Event Description
The customer reported visible smoke coming from the clinitek atlas when powered up during system verification.No flames were seen.There was no report of injury due to this event.
 
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Brand Name
CLINITEK ATLAS - LONG DOOR
Type of Device
CLINITEK ATLAS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SPARTAN MEDICAL
22740 lunn road
cleveland OH 44149
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key7233920
MDR Text Key98984653
Report Number3002637618-2018-00012
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Service and Testing Personnel
Device Catalogue Number10317674
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2018
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 Unknown
Patient Sequence Number1
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