MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report the smoke.A siemens customer service engineer (cse) was dispatched to the customer site.The cse identified a failed power supply and replaced it.The cause of the smoke is a power supply failure.The instrument is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
Smoke was emitted from an advia centaur xp instrument.The instrument was powered off and unplugged by the hospital fire squad.There were no injuries to laboratory personnel and no patient samples were affected due to the smoke emitted from the system.
Additional Manufacturer Narrative
The initial mdr 2432235-2017-00593 was filed on nov 02, 2017.Additional information (10/11/2017): the customer service engineer (cse) replaced the reagents.The cse ran quality control, which was within range.A siemens headquarter support center (hsc) specialist evaluated the data related to the event.The components in the power supply are flammability rated and will not catch fire when they fail.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6997772
• Report Number: 2432235-2017-00593
• Device Sequence Number: 16518162
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1