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

Catalog Number 10332185

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Customer reported that they saw and smelled smoke from the instrument and unplugged the unit.There was no report of injury due to this event.

Manufacturer Narrative

Customer has been provided with new instrument (clinitek status+).Customer indicated that replaced instrument is operational.The cause for the smoke came out of the instrument is unknown.

• 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: 4669223
• MDR Text Key: 19358635
• Report Number: 1217157-2015-00043
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10332185
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1