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

Model Number	APTIO
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse confirmed the safety cover for the rsm electrical plate was missing.The cse placed tape and a sign onto the rsm as a warning to the operator.The rsm electrical plate is located in the rsm cabinet, which should only be accessed by service in case of an error.Siemens is investigating the issue.
Event or Problem Description
An aptio automation system was discovered to be missing the safety cover for the electrical plate inside the refrigerated storage module (rsm).There were no injuries due to the missing safety cover.
Additional Manufacturer Narrative
The initial mdr 2517506-2017-00886 was filed on 19-dec-2017.Additional information (19-feb-2018): a siemens customer service engineer replaced the missing safety cover for the electrical plate inside the refrigerated storage module on february 19, 2018.The cause of the missing safety cover is unknown.This device is operating according to specifications.No further evaluation of this device is required.

• Brand Name: APTIO
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7128352
• Report Number: 2517506-2017-00886
• Device Sequence Number: 2036878
• Product Code: JJE
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1