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

Model Number	VERSACELL X3
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).Siemens noted that there was evidence of poor barcode labels.A customer service engineer (cse) was dispatched to the customer site to perform troubleshooting.The cse observed that a sample tube was picked up low on the tube and drop inside the system.The cse performed the following services and monitored the system's performance: replaced the f/o (fiber optics), r axis motor and gearbox, wrist assembly, and x-axis tg (tragentory generator).The system was verified and performed with no errors post-service repairs.Siemens reviewed the information provided, and the service performed and concluded that the x-axis tg replacement resolved the issue.The customer is satisfied with the service performed.The system was verified and operating as intended.No further evaluation of the device was required.Mdr 2247117-2021-00009 was filed for the same event.
Event or Problem Description
The customer informed siemens that the versacell x3 system dropped sample tubes.The customer reported that sample tubes were dropped inside the system and contaminated samples in the rack.There are no known reports of adverse health consequences due to the dropped sample tubes.

• 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: 11529703
• Report Number: 2247117-2021-00010
• Device Sequence Number: 4510562
• Product Code: DGC
• UDI-Device Identifier: 00630414595177
• UDI-Public: 00630414595177
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 02/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1