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

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

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 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
• Type of Device: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10951
• Manufacturer (Section G): DIATRON MI PIC; registration: 3009297077; tablas str. 39; budapest, H-109 7; HU H-1097
• Manufacturer Contact: benley saint-jean ; 511 benedict ave; tarrytown, NY 10591 ; 9145242398
• MDR Report Key: 8444229
• MDR Text Key: 139582110
• Report Number: 2432235-2019-00106
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1