BENOIT SYSTEMES, FSN-2022-01, LIGHT DRIVE 2.1
Benoit Systemes informs you of an important communication pertaining to the safety of the above-mentioned products.
Our records show that you received one or several of the above-mentioned products. Identified incident We have been made aware of a preoccupying malfunction, potentially dangerous without harm to individuals, of a 12 Ah battery put into service in June 2018. At the end of the charging process, a thermal runaway has occurred, increasing both temperature and pressure within the battery pack, and leading to a carbon gas venting during the battery wreckage. This is generally caused by an overheating of one or several cells inside the pack, hence the self-combustion followed by a venting of carbon dust, sometimes along with a whistling sound. In use for 4 years, this battery was reaching its end-of-life when the malfunction occurred. We compared this incident to a similar one, thus allowing us to identify the battery batch that may be concerned by this malfunction. You delivered to one or several customers, during this period in 2018, a power add-on fitted with a battery of this same batch.
Fabrikant: BENOIT SYSTEMES
Product: LIGHT DRIVE 2.1
Datum FSN: (documentdatum) 27-06-2022
Waarschuwing van de fabrikant
Dit bericht is een waarschuwing van de fabrikant. Na het op de markt brengen van een medisch hulpmiddel is de fabrikant verplicht het hulpmiddel te volgen en waar nodig te verbeteren. Wanneer sprake is van een risico voor de gebruiker moet de fabrikant actie ondernemen. De fabrikant informeert gebruikers en de inspectie over deze actie met een waarschuwing (Field Safety Notice). Zie ook waarschuwingen medische hulpmiddelen. Dit hoort bij het toezicht op medische technologie.