MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Model Number	ACP
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still ongoing to determine the root cause of the event.
Event or Problem Description
The customer contacted the service assistance for a canoe ethernet communication or can problem (software issue).The distributor fse checked the modules and found that the track corner of the automation system was not responding.He found evidence of fire on one of track corner control boards and on the cables attached to the board.The malfunction occurred during the installation of the accelerator a3600 system, so the event did not impact any patient.Nobody in the laboratory noticed smoke nor had to intervene to extinguish the possible fire.There are no reports of adverse health consequences due to the fire and the smoke.
Additional Manufacturer Narrative
The impacted control board has been shipped back to inpeco for being analyzed by inpeco r&d department.The impacted board was affected by a non-conformity notified by board supplier.According to tests performed by inpeco r&d and supplier, the non-conformity leads to an overheating of the board, that cannot cause the increase of temperature such to create fire and smoke, but just the stopping of the track corner motor.It has been evaluated as improbable that the non-conformity is the only cause of the event: other factors of the laboratory environment and conditions have likely contributed to this specific event at acp.353.During the investigation, it was not possible to identify these factors nor during the internal tests performed by inpeco r&d.Given the above, the event has been evaluated as a singular not reproducible event, with no other occurrence received from the field.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 8707294
• Report Number: 3010825766-2019-00006
• Device Sequence Number: 11315567
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)190430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: No Information
• Device Model Number: ACP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1