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: SOMATOM EMOTION 16; SYSTEM, X-RAY, COMPUTED TOMOGRAPHY
  • 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
 

SOMATOM EMOTION 16; SYSTEM, X-RAY, COMPUTED TOMOGRAPHY Back to Search Results
Model Number 10165977
Device Problems Fire (1245); Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 06/27/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, it was reported that the system operator completed a patient exam and left the system in an idle state.Approximately 1 hr later the smoke transducer detected an event and alarmed.The doctor on duty found fire in the ct room and security personnel extinguished the fire.Many components of the system were burned, however, no patient or hospital personnel were injured.This event occurred in (b)(6).
 
Manufacturer Narrative
At this time, siemens is conducting a complete investigation of the reported event.The investigation is ongoing and no conclusion has yet to be determined.A supplemental report will be filed at the conclusion of the investigation when a root cause has been established.This event occured in (b)(6): hospital information: (b)(6) hospital.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOMATOM EMOTION 16
Type of Device
SYSTEM, X-RAY, COMPUTED TOMOGRAPHY
Manufacturer Contact
felix akinrinola
51 valley stream pkwy.
malvern, PA 19355
6102192119
MDR Report Key4169087
MDR Text Key18541150
Report Number2240869-2014-05469
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050297
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Remedial Action Inspection
Type of Report Initial
Report Date 06/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10165977
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2005
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-