MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL X3

Model Number	VERSACELL X3
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to inform that a staff member of the hospital was accessing the electric box to set up a new line on the day of the event.Siemens dispatched a customer service engineer (cse) to the customer site.Siemens confirmed that the versacell x3 system was the only system affected and damaged beyond repair.Siemens concluded that the hospital's electrical department was working on the electrical system that provided power to the versacell x3 system.The instruments connected to the vesacell x3 were not using the same power line and were not affected.Siemens confirmed that the versacell x3 system was replaced with a new one and has been operational at the customer site.The system was verified and operating as intended.No further evaluation of the device was required.
Event or Problem Description
The customer informed siemens that smoke emitted from inside the versacell x3 system.The customer did not observe flames from the system and contacted the fire department.The customer informed that no one from the staff was injured or harmed due to the event.There are no known reports of adverse health consequences due to the smoke emitted from the versacell x3 system.

• Brand Name: VERSACELL X3
• Common Device Name: VERSACELL X3
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• MDR Report Key: 10657713
• Report Number: 2247117-2020-00048
• Device Sequence Number: 16908889
• Product Code: JJE
• UDI-Device Identifier: 00630414595177
• UDI-Public: 00630414595177
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K970227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/09/2020

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: VERSACELL X3
• Device Catalogue Number: 10793839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1