MAUDE Adverse Event Report: INPECO SA APTIO AUTOMATION; LABORATORY AUTOMATION SYSTEM

Model Number	AP2
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation and the analysis of the root cause have been completed by product distributor fse.The fse found that the cause of the sirius board burning was due to a wrong connection of the cable with part number 475283020 conducting 24v.The issue was a single event likely due to a manufacturing problem.No other occurrence was reported from the field.Since the event occurred during the automation system installation phase, there were no patient samples involved.The fse, who is a trained person on the use of the system, was on site and was working on the impacted module.All the electrical components included in the automation system, are tested for flame retardancy and they have a flammability rating at least v-2: in case of fire the electric parts are auto extinguishing in 10-30 seconds without any intervention of service and laboratory personnel.The fse replaced the atr sirius board using the correct cable connection.There was no injury associated to the event neither for the laboratory personnel nor for the fse.After the replacement and the reprogramming of the electrical board, the atr is working as expected and no similar event has been reported from the field.As immediate action, the fse replaced the damaged components.No preventive action is required according to investigation findings.There is no need to conduct a field safety corrective action since the event was a single occurrence and, as confirmed by the product distributor also, the event was not due to a design issue, so it has been evaluated not necessary to implement a design change.
Event or Problem Description
The product distributor has notified inpeco that, during the installation phase of the automation system, smoke and burning smell were coming from the sirius board (electronic board) of the active track return (atr).Atr is a device that allows the carrier to return to the main lane of the track from the secondary lane, avoiding collision with carriers coming form the main lane.The board was found burned and it was replaced by the product distributor service personnel (fse).

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia, 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 8612226
• Report Number: 3010825766-2019-00005
• Device Sequence Number: 1860038
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)181220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: AP2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1