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

Catalog Number 10332185

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Mechanical Jam (2983)

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

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Customer reported that printer paper was jammed and had a burn mark on it.Customer also reported that they saw smoke came out from area of printer.Customer indicated that they powered off instrument and unplugged it immediately.Customer stated that there was no harm or injury to the operator or patient due to this incident.

Manufacturer Narrative

Customer is being offered to exchange the instrument with a remanufactured system.The cause for the smoke came out of printer area is unknown.

Manufacturer Narrative

Customer has been replaced with remanufactured instrument.Customer indicated that replaced instrument is working ok and they do not need any further assistance.Customer did not follow instruction provided by siemens personnel on returned label and sent affected instrument to other siemens site.Affected instrument is lost in transit therefore no further investigation will be possible.The root cause for this event 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: 4521041
• MDR Text Key: 5493661
• Report Number: 1217157-2015-00017
• 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,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

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
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1