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

Catalog Number 10636672

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens is in process of investigating the event.The root cause for the event is unknown.

Event Description

Customer smelled smoke and saw the printer paper burn.Customer turned off internal printer function immediately and removed the thermal paper to stop the incident.There was no report of injury due to this event.

Manufacturer Narrative

Siemens headquarter support center (hsc) team investigated customer returned instrument.Analysis: hsc representative connected returned clinitek advantus to mains power, powered on instrument with no issues noted.Using the instrument's setup menu, attempted to run a printer test, no print occurred.He replaced the printer with another known functioning printer and reran the printer test, successfully printed the test print.He ran a series of 10 printer tests and they were all running successful.The internal printer was designed to be replaced by the customer should there be any failures of the printer during the life of the instrument.The root cause of the event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CT ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): KIMBALL ELECRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 62080 ; PL 62080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5455382
• MDR Text Key: 39307343
• Report Number: 1217157-2016-00020
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

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: No Information
• Device Catalogue Number: 10636672
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• 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: N
• Patient Sequence Number: 1