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

Catalog Number 10332185

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  No Answer Provided  

Event Description

Customer reported that they plugged instrument in the morning and it started smoking.Customer stated that they powered instrument off and unplugged as soon as they saw smoke and instrument had been taken out of service.There was no report of injury due to this event.

Manufacturer Narrative

Customer has been provided with new instrument.Customer indicated that new system is operational at this time.The cause for the issue is unknown.

Manufacturer Narrative

Investigation of the instrument determined that the root cause was a failure of d16 on the main pcb.D16 is the overvoltage protector diode, which blows if the voltage applied to instrument is too high.This complaint is not confirmed.Customer's instrument was replaced and customer is now operational.Siemens product is performing as intended.

• 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: 4757425
• MDR Text Key: 21331505
• Report Number: 1217157-2015-00055
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

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 Health Care Professional
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1