MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK NOVUS

Model Number MS310DN

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the information provided by the customer determined that the event was due to a burst toner cartridge in the printer.Therefore, the printer will not be requested for return and no further investigation necessary.The customer installed another printer they had in stock and is operational.

Event Description

The customer plugged the printer into a new safety outlet and the printer started smoking, no sparks or flames.Customer unplugged the printer.The customer inspected the printer and said a toner cartridge burst inside the printer.There is no report of injury due to this event.

• Brand Name: CLINITEK NOVUS
• Type of Device: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 10619132
• MDR Text Key: 209555828
• Report Number: 3002637618-2020-00052
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140717
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/02/2020

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: Health Professional
• Device Model Number: MS310DN
• Device Catalogue Number: 10697937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2020
• Initial Date FDA Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1