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

Model Number	ACP
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor reported the wire 207 was not securely fastened into relay 2ka1.The loose wire connection caused a short circuit.The 207 wire conducts 24v.The event caused the damage of the 620840010.0 cable and melted parts of the wire tray.The electrical panel is located inside the aliquoter module behind the protective covers.Usually users cannot come in direct contact with the impacted component.In this case the event occured during the module installation so the cover was not in position yet.Only trained service personnel was working on the module.Due to the relay 2ka1 malfunction, the aliquoter module pc was not powered.All the electrical components included in the accelerator a3600 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 the laboratory personnel.The issue was fixed replacing the damaged cable and the relay.The instrument is now performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported a malfunction of the aliquoter module included in the accelerator a3600 automation system due to a short circuit inside the module electrical panel.The small electrical fire caused by the short circuit auto-extinguished without the intervention of any laboratory technicians.There are no reports of adverse health consequences due to the fire and the possible smoke.

• 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: 8539414
• Report Number: 3010825766-2019-00004
• Device Sequence Number: 14067935
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)181219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1