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	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation and the analysis of the affected components have been completed by product distributor service personnel (fse): the cooling unit and the xp4 cooling power connector were damaged.As immediate action, the fse replaced the damaged components (cooling unit and the xp4 cooling power cable).After the replacement, the event has not occurred anymore and the srm worked as expected.The product distributor confirmed that neither the laboratory operators nor the service personnel came in direct contact with the affected components, and that there was no visible fire coming from the module, only smoke.There was no injury associated to the event and the patient sample tubes were not impacted.The root cause was not identified, and it has not been possible to determine if the xp4 cooling power connector was the root cause or a repercussion.However, the issue was a single event with no other occurrence reported from the field.The instrument is performing according to specifications.Neither a further investigation nor a design change is required.
Event or Problem Description
The product distributor has notified inpeco that smoke and strong smell were coming from the cooling unit of the storage and retrieval module (srm).The srm stores sample tubes from the automation system in a temperature controlled and protected environment.Neither the laboratory staff nor the service personnel (fse) were injured due to the event.There was no need for the laboratory to be evacuated.

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, ticino 6883 ; SZ 6883
• MDR Report Key: 8296682
• Report Number: 3010825766-2019-00001
• Device Sequence Number: 1953256
• Product Code: JQP
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)161024
• 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): 02/01/2019

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: No Information
• Device Model Number: AP2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1