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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) observed sparks while replacing an electrical relay for the bulk input module (bim) on an aptio automation system.The aptio automation system was under the control of a siemens customer service engineer (cse) at the time of the event.There was no report of smoke or flame.There was no delay in processing samples.The spark was caused by the installation of an incorrect part number relay in the bim.The cse obtained the correct part and installed it without issue.The instrument is performing within specifications.No further evaluation of this device is needed.
Event or Problem Description
On (b)(6) 2020 a siemens customer service engineer (cse) observed sparks while replacing an electrical relay for the bulk input module (bim) on an aptio automation system.There was no report of smoke or flame.There was no delay in processing samples on the aptio automation system.There are no known reports of patient intervention, or adverse health consequences due to the observed sparks.

• Brand Name: APTIO AUTOMATION BY SIEMENS
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 9687462
• Report Number: 2517506-2020-00049
• Device Sequence Number: 3363897
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1