MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The siemens customer service engineer (cse) performed service repairs on the aptio automation system and observed the issue while troubleshooting robot configuration errors.The cse confirmed that all covers were secured and replaced the motor driver board.Siemens noted that the issue remained and performed additional services, including installing a new motor driver and replacing the tilting tube assembly.The cse reprogramed the stepper motor driver board, downloaded drivers, and installed firmware.The system was verified, and the module was operational.Siemens monitored the system's operation for a few days and identified the motor's temperature was normal.The cse noted no other issue.Siemens is investigating the event.
Event or Problem Description
Siemens was informed that a motor was overheating on an aptio automation system by siemens.A customer service engineer (cse) was onsite to service the system and identified the aliquoter module tube tilter motor was hot and disconnected power to the motor.There are no reports of patient intervention or adverse health consequences due to the motor overheating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 22517506-2021-00311 on 03-nov-2021.Additional information (05-nov-2021): siemens reviewed the information and determined that the robot arm stepper motor driver that was used on-site included the wrong configuration and caused the stepper motor to overheat.Siemens determined the pre-programmed driver board comes pre-installed with the configuration for a new style motor and was not directly compatible with the older version of the motor that was installed on the system.Siemens concluded the system required an unprogrammed driver board to load the compatible program and identified no issue with the stepper motor.The aptio automation system by siemens is operating as intended, and no further evaluation of the system was required.Siemens updated section h6 (investigation conclusions) to include a new code.

• Brand Name: APTIO AUTOMATION
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; registration #: 3005509212; val della torre, torino 10040 ; IT 10040
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 12747155
• Report Number: 2517506-2021-00311
• Device Sequence Number: 20050918
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043546
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown