MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS; CT ATLAS

Catalog Number 10309477

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2015

Event Type  malfunction  

Event Description

Customer reported that they heard a sound from the printer (lexmark t420) and saw smoke came out of it.Customer stated that they unplugged the printer immediately.There was no report of injury due to this event.

Manufacturer Narrative

Customer confirmed that the smell did not affect anyone in the lab and no laboratory personnel have sought medical treatment.Customer had been asked to contact their facilities management immediately and removed the printer from the lab area to a location where it was not a hazard to personnel or the facility.Neither siemens field service engineer (fse) nor customer could confirm when or who installed the lexmark t420 printer on clinitek atlas ((b)(4)).The printer (lexmark t420) has been replaced with new siemens authorized printer (lexmark 310dn).System is fully functional on departure.Please note: 1.The model of the printer (lexmark t420) is not a siemens authorized printer for the clinitek atlas.2.The issue was with the printer (lexmark t420) and not the instrument (clinitek atlas).Instrument is performing as intended.

• Brand Name: CLINITEK ATLAS
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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 Key: 4535917
• MDR Text Key: 16988489
• Report Number: 1217157-2015-00022
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2015

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: Medical Technologist
• Device Catalogue Number: 10309477
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2015
• Initial Date FDA Received: 02/23/2015
• 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 Number: 1