MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

The customer reported that smoke came out of the instrument.There was no report of injury due to this event.

Manufacturer Narrative

The customer is being provided with instrument exchange information.The further investigation will not be possible as instrument will not be returned for investigation.The event is not confirmed.

Manufacturer Narrative

Customer indicated that they have been provided all of the information to make instrument exchange decision and as of right now they do not want to exchange an instrument.If they decide to proceed with the out of contract exchange they will call back.The event will not be investigated further as the instrument will not be returned for investigation.The cause for the event is unknown.Instrument was not returned.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4148849
• MDR Text Key: 4910371
• Report Number: 1217157-2014-00150
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1