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

Device Problems Smoking (1585); Electrical Shorting (2926)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

After the damaged power supply replacement, the automation system is performing according to specifications.The investigation is still ongoing to determine the root cause.

Event Description

The distributor notified inpeco about the failure of a 24vdc, 20a power supply installed in the flexlab automation system track.The operator was notified of the issue by a power supply error (1202).The operator did not report any smoke or flames.When the component was replaced, the fse noticed visible signs of burning on an internal capacitor.The power supply was contained within the track behind a plexiglas cover and the metal track cover, so the operator could not come in direct contact with the damaged component.The distributor reported that the failure did not cause any injury or impact to patient result processing.The event did not cause the damage of any other track components.

Manufacturer Narrative

The initial report (3010825766-2020-00006) has been submitted on july 27th, 2020.Additional information (february 22nd, 2021): per inpeco's request, the damaged component was sent back to further investigate the cause of the malfunction.The capacitors of the power supply appear to be swollen.The damage of the capacitors caused the leak of the electrolyte and the short circuit.The failure can be a consequence of the ageing and of the normal wear and tear since the component was in use for 7 years.The design of inpeco device has been evaluated appropriate since the automation system is certified for electrical safety and the involved power supply is installed inside a fire enclosure which avoids the flames propagation in case of malfunction.The investigation did not highlight the need of any design change.After the damaged power supply replacement, the automation system is continuing to work according to specifications.No further actions are foreseen.The codes in section h6 have been updated in accordance to the investigation conclusions.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 10325080
• MDR Text Key: 200369651
• Report Number: 3010825766-2020-00006
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1