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

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site for another issue, and the smoking incident occurred as the cse was replacing a system display component during system troubleshooting.The cse found that the pcb and cable on the advia 560 hematology system were burnt.A replacement order was put in for the damaged parts.Siemens is investigating the issue.

Event Description

A siemens customer service engineer (cse) observed smoke as well as a burning smell from the customer's advia 560 hematology system (serial number: (b)(4)) while replacing a system display component during system troubleshooting.The instrument was then shut down.There was no delay in testing as the customer had a backup system to process samples.There are no known reports of adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2021-00164 on 02-jul-2021.Additional information (02-aug-2021): the advia 560 hematology system was switched off while the part replacement took place.It is unknown if a second new display was installed successfully.Siemens healthcare diagnostics inc attempted to contact the country multiple times but no response was received.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Type of Device: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12108010
• MDR Text Key: 259639866
• Report Number: 2432235-2021-00164
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• PMA/PMN Number: K112755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1