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

Catalog Number 10282611

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

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 reported that they smelled paper burn.They opened printer cover and found out that thermal paper was black and had a hole in it.Customer indicated that printer got burnt.There was no report of injury due to this event.

• 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: 5486433
• MDR Text Key: 40179294
• Report Number: 1217157-2016-00025
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10282611
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• 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