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

Catalog Number 10282611

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2014

Event Type  No Answer Provided  

Event Description

Customer reported that they saw smoke from printer area after urine was spilled into the printer by them.There was no report of injury due to this event.

Manufacturer Narrative

The customer will be getting an exchange unit.The event has occurred due to an operator error.

• 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, 6208 0; PL 62080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4294619
• MDR Text Key: 5052771
• Report Number: 1217157-2014-00181
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2014

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
• Device Catalogue Number: 10282611
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/03/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1