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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An instrument operator was exposed to a hot surface while performing maintenance on the tube sealer module of an aptio automation system.A siemens customer service engineer (cse) was dispatched to inspect the instrument.The cse did not find an instrument malfunction.It is unknown if the operator followed the maintenance instructions in the operator's guide to remove all sample tubes from the area and wait approximately 30 minutes for the sealing head to cool before performing maintenance.The instrument is performing within specifications.No further evaluation of this device is needed.
Event or Problem Description
An instrument operator was exposed to a hot surface while performing maintenance on the tube sealer module of an aptio automation system.The operator reportedly had their thumb get caught in the hot sealer head.The safety shield was up on the sealer module.The operator went to the emergency department.The emergency department reported the skin on the thumb was not broken, did not bleed and there appeared to be no damage to the thumb.There are no known reports of patient intervention or adverse health consequences due to the heat exposure from the sealer module.

• 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
• MDR Report Key: 9369135
• Report Number: 2517506-2019-00441
• Device Sequence Number: 16869249
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/25/2019

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: 11/01/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1