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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report that the operator of an aptio automation system cut his finger on the shutter mechanism of the storage and retrieval module (srm).The operator put a band aid on the cut and did not seek additional medical treatment.The cause of the cut to the finger is an unintented use error of the operator pushing the rack back into the srm.The system is performing within specifications.No further evaluation of the system is needed.
Event or Problem Description
The customer contacted siemens to report that the operator of an aptio automation system cut his finger on the shutter mechanism of the storage and retrieval module (srm).There are no known reports of patient intervention or adverse health consequences due to the cut on the finger.

• Brand Name: APTIO AUTOMATION
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10439545
• Report Number: 2517506-2020-00260
• Device Sequence Number: 16884944
• 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): 08/21/2020

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: 07/30/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1