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

Model Number	FLX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The procedure followed to install the hardware kit indicates first of all to "cut off energy supplies".The fse asked by email that the laboratory electrical power supply was off, but the main electrical panel was still connected to power.The fse did not checked that the circuit was dead before starting the replacement and did not cut off the automation system power supply as recommended in the procedure.The event was caused by the fse error.The hardware kit and the installation procedure were reviewed and there is no need of changes.The automation system is performing as expected.No further actions are required.
Event or Problem Description
An inpeco fse received an electrical shock while he was working on the automation system, specifically his right hand touched a live 240v wire while he was replacing the circuit breaker of a distribution board of the high volume storage.

• Brand Name: FLEXLAB
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9731889
• Report Number: 3010825766-2020-00002
• Device Sequence Number: 2401780
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)190430
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: Health Professional
• Device Model Number: FLX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1