MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS AUTOSCAN-4

Model Number B1012-1R

Device Problem Device Inoperable (1663)

Patient Problem Not Applicable (3189)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that the customer smelled something burning from the instrument; however, the exterior of the instrument was not hot to the touch.The instrument's drawer was open.The customer tried to close the drawer by going thru the software as if running a panel and 5 to 10 minutes later observed possibly white smoke emitting from the instrument through the drawer opening.The instrument was not powered but the power cord was disconnected from the electrical source.Although the smoking issue did not set off any fire alarms, a code red was issued to indicate an emergency.It was also reported that the smoke did not fill the room but it aggravated the user's existing cough.Medical intervention was not required.The hospital's biomed personnel removed the instrument from the lab.

Manufacturer Narrative

(b)(4).Siemens service engineer replaced the power supply board, a/d board and adjusted the instrument as needed.

• Brand Name: AUTOSCAN-4
• Type of Device: AUTOSCAN-4
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 4293219
• MDR Text Key: 5191851
• Report Number: 2919016-2014-00044
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1012-1R
• Device Catalogue Number: B1012-1R/SMN1046117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1