MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120 WITH AUTOSAMPLER

Model Number	ADVIA 120 WITH AUTOSAMPLER
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse determined that the advia 120 hematology system's uninterruptible power supply (ups) had failed internally and was smoking.The cse unplugged the ups from the wall and from the analyzer and replaced it with a new ups.The cause of the ups failure was due to the multiple power surges in the lab.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer observed smoke and an electrical burning smell coming from the back of their advia 120 hematology system by the outlet plug after having several power surges in their lab.No flames were observed and there are no reports of delays in patient testing.There are no reports of adverse health consequences due to this event.

• Brand Name: ADVIA 120 WITH AUTOSAMPLER
• Common Device Name: ADVIA 120 WITH AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 10889378
• Report Number: 2432235-2020-00459
• Device Sequence Number: 2829699
• Product Code: GKZ
• UDI-Device Identifier: 00630414574868
• UDI-Public: 00630414574868
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K971998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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 120 WITH AUTOSAMPLER
• Device Catalogue Number: 10360958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1