MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer reported that smoke was observed when the system was powered on after the user had difficulty opening and closing the front cover of the advia 560 hematology system during control measurement.While forcibly trying to close the front door of the advia 560 hematology system, the customer pinched the led cable and it shorted.The cause of the smoke coming from the advia 560 hematology system was due to the pinched led cable.The cause of the event was due to the lack of required customer maintenance.The customer is currently using an alternate advia 560 hematology system for patient sample testing.
Event or Problem Description
A customer observed smoke coming from the right side of the advia 560 hematology system.The smoke was observed from the central processing unit (cpu) board.The customer turned off the power and switched to an alternate advia 560 hematology system.There were no known reports of harm or injury due to the smoke from the advia 560 hematology system.There were no patient testing delays and no impact on patient results or patient care.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Common Device Name: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10951
• MDR Report Key: 8444229
• Report Number: 2432235-2019-00106
• Device Sequence Number: 10832322
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1